A Father's Pain Eased by Holding His Child Safe

Neuromodulation technology, from spinal cord stimulation to a phone app, frees a Marine to care for his girl.

Pain and Movement|Oct.29, 2021

Most every parent has had that particular nightmare.

The one where a child is vulnerable and can't be helped. The most primal instinct of protection thwarted by circumstance or bad fortune. It doesn't really matter what the cause, only the effect.

"I think the saddest moment of my adult life was when I realized I couldn't pick up my two-year-old daughter. I couldn't physically do it. I couldn't safely do it."

Robert, a Marine officer and lawyer who was, "used to being in control," found himself in a world-turned-upside-down scenario. "I was in a position where if something happened, I could not be the responsible party to take care of her by myself. And that's a terrifying thing as a young father."

Robert was not accustomed to feeling vulnerable. He was the guy who worked hard, adapted as needed and moved forward – until he couldn't.

After breaking his leg in three places, undergoing surgery and being deemed not physically qualified to continue with Marine Officer Training School at the time, Robert focused his efforts on earning his master's in international law in Scotland and beginning his domestic law school education in Arizona. He did not give up on his dream of being a Marine, going on active duty in 2015.

Robert McManimom and family

"Felt Like Daggers."
The heavy packs, long hikes, and extensive running began to take their toll on his previously injured leg. "Over time, apparently I had been breaking that ankle, causing really serious injury," said Robert. "Turns out I had a sizable defect in my ankle, had to have surgery and suffered severe peripheral nerve damage that went untreated for a while."

Post-operative pain can be a challenge under the best of circumstances, and these were far from those. "Immediately after the operation, I had very intense pain. At first, I was numb, but over time the pain increased to the point that I couldn't even take a bath because of the hyper-sensitivity. Any contact with the water, regardless of temperature, felt like daggers. I likewise couldn't sleep because my leg felt like it was being crushed in a vise and every step I took felt like a hammer hitting my leg.

"Over time, the pain became constant and progressive. It got to where I wasn't able to function as a Marine, a lawyer, or even a husband and father because I couldn't do things we would normally do as a family. On top of the physical problems, emotionally that was incredibly difficult to deal with," said Robert.

"We tried so many different medications, with some of them offering short-term relief but not long after starting them, they were not very effective, they didn't halt the progression of the pain area. They also interfered with my ability to think and articulate clearly, which made it tough to do my job."

"I Was Always Chasing the Pain."
"We tried opioids, different physical therapies, some electrostimulation devices, acupuncture and more," said Robert. "But at the end of the day I kept getting worse. Something might be effective for a short time, but I was always chasing the pain, upping the dosages until I was reaching maximums and still not getting good relief.

"There was a point where not only would I have to use a cane and a brace, but it would take a lot just to move from the back of a parking lot to the store. I got to a point where I couldn't even hold my daughter anymore."

As tough as the current limitations were, the future looked even more daunting. "I had actually resigned myself to thinking that I was never going to be able to do certain things again."

Robert realized he needed to explore other options with his care providers. The most invasive option, amputation, was an unfortunate possibility but Robert wanted it to be the last one, preferring to move incrementally in an effort to save the leg. "I visited the Pain Institute of Southern Arizona and found a team that I really trusted, and we began exploring the use of a spinal cord stimulation device," said Robert.

Dr. Effrain Cubillo and Dr. Eric Cornidez, both Interventional Pain Specialists at the Institute, were hopeful that Abbott's Proclaim™ XR SCS device would make a difference for Robert. "The innovations in neuromodulation itself have been pretty remarkable. We have a solution that is much better than it was 10 years ago," said Dr. Cornidez.

His Path to myPath.
After diagnosing the source of his chronic pain, to see if the Proclaim XR would help reduce Robert's pain in the long-term, Dr. Cubillo performed a trial implant, a temporary placement during which Robert would be able to experience the hoped-for pain relief.

"I used NeuroSphere™ myPath™ during the actual trial," said Robert. This device is designed to store pain relief information and assist in communication between the patient and healthcare provider during this crucial period. It allows patients to connect with Abbott support, access educational materials and, most importantly, track pain and related symptom relief progress by giving the patient a tool to chart their experiences throughout the trial period.

"It helped me gain insight to the pain relief I was receiving during my device trial," said Robert. "It allowed me to record my responses to different stimuli, which was helpful information for my doctor."

"With myPath, the patient can tell us not only what percentage relief they are experiencing, but what are some functionalities they can use. They might not receive complete relief, but if they get substantial relief while sleeping better or walking better, that's a home run,” said Dr. Cubillo.

A Visit to the NeuroSphere Virtual Clinic
This data helped inform the decision to place a permanent device, which led to Robert's introduction to the NeuroSphere™ Virtual Clinic app. Until very recently, when people using spinal cord stimulators needed adjustments to their treatment programs, they had to make appointments and travel to and from their caregivers.

But now, remote care is available and very much appreciated by the people who use it.

"One of the great things about the app is that no matter where I am, if there's a usable wi-fi signal, I can request remote care where my doctors can tailor the device settings to match what I'm experiencing. It's all adjustable to my specific use case. If I'm experiencing more pain on one side, they can make the adjustment and same with if I need more intensity or a different program.

"I am able do all this without ever having to make it to an office, especially because I love to travel and now I can. I get the relief I need whether I'm home or in a hotel room."

Day-to-Day is No Longer Pain-to-Pain
The difference in daily concerns can be startling. "Before the implant, I once met a bunch of former colleagues for dinner when I was away from home. I had to take a gallon-sized plastic bag with all my different medications because I didn't know what I would need – and when – that night," said Robert. "Emotionally, carrying a pharmacy with you like that when you just want to meet up with friends is tough."

"Using the controller app is easy, intuitive and, since it's on my phone, very easy to access if I need to make adjustments myself," said Robert. "One of the best things about the app is I can anticipate issues and deal with them before the pain arrives. I can turn up the intensity before exercising, knowing that it helps me deal with possible flare-ups afterwards. This lets me exercise more which is better for my overall health."

Physicians echo these sentiments. "There are now fewer barriers for patients and the app allows them to take control of their own pain and their own lives," said Dr. Cornidez. "Patients are getting their lives back because of this technology."

"The app is very easy to use, and I tweak and adjust settings as necessary," said Robert. "It doesn't take more than 30 seconds to adjust my spinal cord stimulator and it helps my mood that I feel like I can depend on the results. My confidence in the treatment has increased along with the feeling that I am moving forward and progressing.

"The device has given me enough freedom to where I now go back out and do things. I can take long walks, experience things with my friends and have meaningful conversations, not worried that I'll get lost midway through a sentence because of my meds. It's hugely liberating."

But for all the formerly taken-for-granted moments that Robert can now enjoy, it's clear that his shortest path to happiness is the one he can walk with his daughter nestled safely on his shoulders. "The times I couldn't chase her around broke my heart because that's all I wanted to do. To spend time with her," said Robert. "A two-year-old can't understand why you scream when she touches your leg. Most adults can't. Now that I'm able to push her on the swings and play games, I realize that I can have those moments I thought I'd lost forever.

"I know that she is safe beside me."

This story reflects one person's experience; not everyone will experience the same results. Talk to your doctor about the benefits and risks of your treatment options.



Read this section to gather important prescription and safety information.

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.

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.

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.

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 Abbott product information page at neuromodulation.abbott.

The following warnings apply to this neurostimulation system.

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 Abbott 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 system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off.

Electrosurgery. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm the neurostimulation system is functioning correctly after the procedure.

During implant procedures, if electrosurgery devices must be used, take the following actions:

Use bipolar electrosurgery only.

  • Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator.
  • Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible.
  • Set the electrosurgery device to the lowest possible energy setting.
  • Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket.

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.

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 Abbott Medical with this system 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 Abbott 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 this neurostimulation system.

General Precautions

  • 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 or damage system components. Patients should avoid getting too close to 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, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).
  • Security, antitheft, and radiofrequency identification (RFID) devices. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also 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 some patients have described as uncomfortable or jolting. Patients should cautiously approach such devices and should request help to bypass them. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device 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. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation 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 Implantation

  • 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 Abbott Medical for evaluation.
  • System testing. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite explanted.
  • 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 Abbott Medical for service.

Hospitals 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:

  • Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.)
  • Stimulation in unwanted places (such as radicular stimulation of the chest wall)
  • Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
  • Persistent pain at the electrode or IPG site
  • Seroma (mass or swelling) at the IPG site
  • Allergic or rejection response to implant materials
  • Implant migration or skin erosion around the implant
  • Battery failure