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« on: September 27, 2008, 09:05:17 AM »

May2002FDA Patient Safety News Homepage
Alert on Implanted Neurostimulators and Diathermy    (Video, print, and e-mail functions)

Now we want to alert you to a serious problem that can occur when patients with neurostimulator implants receive diathermy therapy. If a patient has an implanted neurostimulator, treatment with diathermy can cause heating at the interface where the neurostimulator electrode comes in contact with the body. That can cause tissue damage that can lead to permanent injury or even death.

In 2001, 2 patients who had been implanted with deep brain stimulators and later received diathermy treatment, died as a result. One of them had the diathermy following oral surgery, the other to treat chronic scoliosis. In both cases, the energy from the diathermy treatment caused severe brain damage where the lead electrodes were implanted in the brain.

Medtronic, the manufacturer of the device, subsequently issued a safety alert to physicians, patients and facilities. The alert strongly warned against using diathermy on patients with any of the company's implanted neurostimulation systems, including those for the brain, spinal cord, peripheral nerves or sacral nerve. That includes diathermy of any kind - shortwave, microwave or therapeutic ultrasound. Other manufacturers of implanted neurostimulators have also warned about the dangers of using diathermy on patients implanted with their neurostimulation devices. These firms include Cyberonics and ANS,or Advanced Neuromodulation Systems. Cyberonics makes the NeuroCybernetic Prosthesis System, that stimulates the vagal nerve to help reduce the frequency of epileptic seizures. ANS makes the ANS Renew Neurostimulation System, which stimulates the spinal cord to treat chronic pain.

With all of these neurostimulators the message is clear. Patients with these devices should not have diathermy. And remember, the hazard exists even when the implanted device is turned off. And because diathermy can concentrate or reflect its energy off implants of any size, this warning extends to individual components of a neurostimulation system that might remain implanted even after the device is no longer being used.

Implanted April 2006 for TRD
Explant July 23, 2008, Coil left in Sad
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