Another medical device from Medtronic is under fire. The Food and Drug Administration has issued a Class I recall of Medtronic's deep brain stimulation, or DBS, devices because the external wires may become damaged by the very cap installed to keep them securely attached to the implanted electronics. A Class I recall by the FDA means that there is a reasonable possibility patients using the defective medical device could experience serious, adverse medical effects or even die from the fault.
What a DBS does is send highly-targeted electrical impulses to the brain. Part of the device is implanted in the brain, but it has an external component to allow the patient to change the batteries. The device is used to treat a number of conditions, such as Parkinson's disease, obsessive-compulsive disorder and involuntary muscle contractions. Not all patients with the device are affected, but the problem was widespread enough that Medtronic called it to the FDA's attention in February.
The device has a metal cap that covers the point of insertion. Even though the cap was intended to protect the delicate electronics and keep the external parts from protruding, it is this cap that is causing the problems. In some cases, a connector inside the cap can become twisted, damaging the external wires, which are referred to as leads.
In some cases, the cap damages the leads during the implantation surgery, although the wires may become frayed later. Not all of the devices include the cap at all, and in some cases it is only installed temporarily.
The main fear so far is that the defective medical device simply may not work if the leads become too damaged. The FDA's recall notice, while listing the recall as Class 1, does not indicate that any patients have been harmed so far. Patients whose devices are working properly are not expected to need intervention.
Medtronic has halted production of the device and is making changes in its manufacturing process. Considering how many defective medical devices have turned out to be far more harmful to patients than initially expected, we should watch carefully for further developments.
Source: News Inferno, "Medtronic Deep Brain Stimulator Recall Deemed a Class I by FDA," Cynthia A. Diaz-Shephard, May 6, 2013