Deep Brain Stimulators Could Malfunction or Fail Under Certain Conditions

David Mittleman

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In 1997, the Federal Food and Drug Administration (FDA) approved the use of deep brain stimulation to treat Parkinson’s Disease and certain other neurological disorders. Since then, medical device manufacturer Medtronic has embraced the technology and has aggressively marketed deep brain stimulators, which may also be useful in treating depression. Unfortunately, it appears that some of these devices are at risk of potential failure.

There have been concerns about potential side effects of deep brain stimulation for some time now. New evidence suggests an additional hazard: the devices can malfunction under certain circumstances. Magnets, metal detectors, MRI machines, and other sources of electromagnetic interference may cause deep brain stimulators to reset or fire unexpectedly. In fact, some of the initial studies conducted by the FDA indicated a high prevalence of adverse reactions, some of which were caused by device failure.

This is not the first time Medtronic products have experienced problems. In April of 2004, the company recalled two models of implantable cardiac defibrillators. In February of 2005, Medtronic announced that it was experiencing problems with the batteries in still more of their implantable defibrillators. In February and April of that year, Medtronic also announced recalls of certain external defibrillators. More recently, Medtronic has recalled certain Heparin-coated products used in cardiopulmonary surgery and some implantable infusion pumps.

If you or a loved one uses deep brain stimulation therapy or is considering using it, be sure to ask your doctor about the potential health risks. If you think you have experienced a malfunction with your unit, report the event to the FDA.