INDICATIONS, SAFETY & WARNINGS
Indications and Usage
The AMPLATZER™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.
Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus Allergic drug reaction; Allergic dye reaction; Allergic metal reaction: Nitinol (nickel, titanium), platinum/iridium, stainless steel (chromium, iron, manganese, molybdenum, nickel); Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding ; Brachial plexus injury; Cardiac perforation; Cardiac tamponade; Cardiac thrombus; Chest pain; Device embolization; Device erosion; Deep vein thrombosis; Death; Endocarditis; Esophagus injury; Fever; Headache/migraine; Hypertension/hypotension; Myocardial infarction; Pacemaker placement secondary to PFO device closure; Palpitations; Pericardial effusion; Pericardial tamponade; Pericarditis; Peripheral embolism; Pleural effusion; Pulmonary embolism; Reintervention for residual shunt/device removal; Sepsis; Stroke; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury; Vessel perforation
IMPORTANT SAFETY INFORMATION
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications and Usage: The CardioMEMS™ HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.
Contraindications: The CardioMEMS™ HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.
Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to the following: Infection, Arrhythmias, Bleeding, Hematoma, Thrombus, Myocardial infarction, Transient ischemic attack, Stroke, Death, and Device embolization.
Refer to the User's Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
Insertable Cardiac Monitor
Indications: The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. Confirm Rx ICM Model DM3500 is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
Contraindications: There are no known contraindications for the implantation of the Confirm Rx ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.
Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
Limitations: Patients may use their own Apple‡ or Android‡ mobile digital device to transmit information from their Confirm Rx ICM using the myMerlin™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology connection enabled and data coverage (cellular or WiFi‡) available. The myMerlin™ app provides periodic patient monitoring based on clinician configured settings. Transmission data is resent if not sent successfully. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, ICM memory capacity, clinic environment, schedule/configuration changes or data processing.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
The FreeStyle Libre Flash Glucose Monitoring system is a continuous glucose monitoring (CGM) device indicated for replacing blood glucose testing and detecting trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription.
CONTRAINDICATIONS: Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment.
WARNINGS/LIMITATIONS: Do not ignore symptoms that may be due to low or high blood glucose, hypoglycemic unawareness, or dehydration. Check sensor glucose readings with a blood glucose meter when Check Blood Glucose symbol appears, when symptoms do not match system readings, or when readings are suspected to be inaccurate. The FreeStyle Libre system does not have alarms unless the sensor is scanned, and the system contains small parts that may be dangerous if swallowed. The FreeStyle Libre system is not approved for pregnant women, persons on dialysis, or critically-ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of blood borne pathogens should be taken. The built-in blood glucose meter is not for use on dehydrated, hypotensive, in shock, hyperglycemic-hyperosmolar state, with or without ketosis, neonates, critically-ill patients, or for diagnosis or screening of diabetes. Review all product information before use or contact Abbott Toll Free (855-632-8658) or visit www.freestylelibre.us detailed indications for use and safety information.
INDICATIONS FOR USE
The SJM™ Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning mitral or aortic heart valve. This device may also be used to replace a previously implanted mitral or aortic prosthetic heart valve. The sizer model 905-15 is indicated to confirm size selection of the 15AHPJ-505 and 15MHPJ-505 valves.
The SJM™ Masters Series Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy. The sizer model 905-15 is contraindicated for use with any devices other than the 15 AHPJ-505 and 15MHPJ-505 valves. Any sizer sterilization method other than steam is contraindicated.
POTENTIAL ADVERSE EVENTS
Complications associated with replacement mechanical heart valves include, but are not limited to, hemolysis, infections, thrombus, or thromboembolism, valve dehiscence, unacceptable hemodynamic performance, hemorrhagic complications secondary to anticoagulation therapy, heart block requiring pacemaker implant, prosthetic failure, adjacent cardiac structure interference, heart failure, stroke, myocardial infarction, or death. Any of these complications may require reoperation or explantation of the device.
Risks, Warnings, and Precautions
What Are the Possible Risks 1 Year After the Procedure?
The most common serious risks observed within 1 year of the MitraClip procedure in patients enrolled in the PR DMR Cohort include:
Proclaim™ Elite IPG with BurstDR™ Stimulation
*BurstDR™ stimulation, patented technology exclusively from St. Jude Medical, is also referred to as Burst stimulation in clinical literature.
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Prescription and Safety Information
Read this section to gather important prescription and safety information.
Intended Use: This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system.
Indications for Use: This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.
Contraindications: This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.
MRI Safety Information Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at manuals.sjm.com). For more information about MR Conditional products, visit the St. Jude Medical product information page at sjmprofessional.com/MRI.
The following warnings apply to these components.
Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.
Magnetic resonance imaging (MRI). Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by St. Jude Medical. Physicians should also discuss any risks of MRI with patients.
Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient.
Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.
Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for systemimplantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off.
Electrosurgery devices.Electrosurgery devices should not be used in close proximity to an implanted neurostimulation system. Contact between an active electrode and an implanted IPG, lead, or extension can cause severe injury to thepatient. If use of electrocautery is necessary, first turn off the neurostimulation system.
Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system.
Operation of machines, equipment, and vehicles. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. However, current data shows that most patients using BurstDR™ stimulation therapy do not experience paresthesia. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment.
Burst stimulation during the trial period. The use of BurstDR stimulation during the trial period has not been evaluated for effectiveness.
Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established.
Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.
Device components. The use of components not approved for use by St. Jude Medical may result in damage to the system and increased risk to the patient.
Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.
IPG disposal. Return all explanted IPGs to St. Jude Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.
The following precautions apply to these components.
Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training.
Patient selection. It is extremely important to select patients appropriately for neurostimulation. Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and should be able to operate the neurostimulation system.
Infection. Follow proper infection control procedures. Infections related to system implantation might require that the device be explanted.
Electromagnetic interference (EMI). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system. Patients should avoid getting too closeto these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).
Theft detectors and metal screening devices. Certain types ofantitheft devices, such as those used atentrances or exits of department stores, libraries, and other public establishments, and airport security screening devices may affect stimulation. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which has been described by some patients as uncomfortable or jolting. Patients should use caution when approaching such a device and should request assistance to bypass the device. If they must proceed through the device, patients should turn off the IPG and proceed with caution, being sure to move through the detector quickly.
Wireless use restrictions. In some environments, the use of wireless functions (e.g., Bluetooth® wireless technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. (Bluetooth® is a registered trademark of Bluetooth SIG, Inc.)
Mobile phones. The effect of mobile phones on neurostimulation systems is unknown; patients should avoid placing mobile phones directly over the system.
Sterilization and Storage:
Single-use, sterile device. The implanted components of this neurostimulation system are intended for a single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not resterilize or reimplant an explanted system for any reason.
Storage environment. Store components and their packaging where they will not come in contact with liquids of any kind.
Handling and Implementation:
Expiration date. An expiration date (or “use-before” date) is printed on the packaging. Do not use the system if the use-before date has expired.
Care and handling of components. Use extreme care when handling system components prior to implantation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components.
Package or component damage. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to St. Jude Medical for evaluation.
System testing. To ensure correct operation, the system should always be tested after implantation and before the patient leaves the surgery suite.
Device modification. The equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to St. Jude Medical for service.
Hospital and Medical Environments:
High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG.
Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system.
External defibrillators. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established.
Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable
In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this IPG:
The Supera Peripheral Stent System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters of 4.0 to 6.5 mm, and lesion lengths up to 140 mm.
The Supera Peripheral Stent System is contraindicated in:
The Supera Peripheral Stent System should only be used by physicians and medical personnel trained in vascular interventional techniques and trained on the use of this device.
Magnetic Resonance Imaging (MRI)
A patient with this device can be scanned safely only under specific conditions. Failure to follow the conditions may result in severe injury.
Non-clinical testing has demonstrated the Supera Stents are MR Conditional for lengths up to 250 mm. A patient with this stent can be scanned safely, immediately after placement, under the following conditions:
for 15 minutes of scanning (per pulse sequence), operating in the Normal Operating Mode (i.e., MR system mode of operation where there is no physiological stress to the patient). The legs of the patient should not be touching during the procedure.
Potential adverse events include, but are not limited to:
Prior to use, please reference the Instructions for Use at www.abbottvascular.com/ifu for more information on indications, contraindications, warnings, precautions, and adverse events.
Brief Summary: Prior to using these devices, please review the Clinician’s manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system. Indications for Use: Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson’s disease that are not adequately controlled by medications, and unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. Contraindications: Patients who are unable to operate the system or for whom test stimulation is unsuccessful. Diathermy, electroshock therapy, and transcranial magnetic stimulation (TMS) are contraindicated for patients with a deep brain stimulation system. Warnings/Precautions: Return of symptoms due to abrupt cessation of stimulation (rebound effect), excessive or low frequency stimulation, risk of depression and suicide, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), electromagnetic interference (EMI), proximity to electrosurgery devices and high-output ultrasonics and lithotripsy, ultrasonic scanning equipment, external defibrillators, and therapeutic radiation, therapeutic magnets, radiofrequency sources, explosive or flammable gases, theft detectors and metal screening devices, activities requiring excessive twisting or stretching, operation of machinery and equipment, pregnancy, and case damage. Patients who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted. Adverse Effects: Loss of therapeutic benefit or decreased therapeutic response, painful stimulation, persistent pain around the implanted parts (e.g. along the extension path in the neck), worsening of motor impairment, paresis, dystonia, sensory disturbance or impairment, speech or language impairment, and cognitive impairment. Surgical risks include intracranial hemorrhage, stroke, paralysis, and death. Other complications may include seizures and infection. Clinician’s manual must be reviewed for detailed disclosure.
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