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Medtronic Deep Brain Stimulation Lead Cap Recall

On May 2, Medtronic, Inc., the manufacturer of deep brain stimulation (DBS) devices, announced a recall of its deep brain stimulation lead kits due to a defect in one of the components called the lead cap.  The recall applies to 1,598 devices distributed in the US between April 2006 and February 28, 2013.  This could impact some people with Parkinson’s disease who have undergone deep brain stimulation surgery.

The lead cap is a temporary cover that is placed over the near tip of the deep brain electrode after the latter has been implanted in the brain.  The lead cap is used by surgeons to protect the exposed wires until the system’s battery pack is implanted in the chest, usually performed in a second operation.  The lead cap is screwed into the tip of the electrode but can damage the electrode if placed too tightly.  A damaged electrode may not deliver adequate therapy, which can lead to a poor treatment result.  In the worst-case scenario, a person impacted by a defect in the lead cap may require another operation to replace the DBS electrode.

The US Food and Drug Administration (FDA) classified this as a Class I Recall, indicating serious risk to individuals.  Medtronic notified physicians of this issue in February 2013, after receiving reports of DBS leads being damaged due to twisting of the connector within the lead cap during DBS surgery.  Lead damage was reported in 0.25 percent of devices, or 1 in 400 devices.

What Does It Mean?

The Class I recall is normally applied when there is reasonable probability that the use of a product will cause serious adverse health consequences or death.  However, in this case, there have been no reports of permanent harm or injury to patients as a result of the faulty cap.  The primary concern is damage to the DBS device itself, with resultant inadequate relief of Parkinson’s symptoms, and the possibility of needing another brain operation to correct the damage.

From the perspective of a person with Parkinson’s disease, if you have already undergone brain surgery for Parkinson’s and your DBS system is working normally, there is no cause for concern.  Damage to the DBS electrode from over-tightening the faulty lead cap occurs at the time of DBS implantation.  If the lead is damaged, the problem will likely be detected at the first post-operative visit, when the DBS system is first turned on and programmed.

For neurosurgeons who do not use the lead cap, the recall does not apply. According to Medtronic, a manufacturing change to address the issue is currently under FDA review.  In the meantime, the company has issued modified instructions to physicians who use DBS lead caps.

Any malfunctions or adverse events related to a lead cap should be reported to the FDA's MedWatch Program at http://www.fda.gov/MedWatch or (800) 332-1088 to request a reporting form, and Medtronic Neuromodulation Technical Services at (800) 707-0933, weekdays from 7:00 AM to 6:00 PM CST.

If you have any questions about deep brain stimulation, please contact the Parkinson's Disease Foundation's toll-free HelpLine at (800) 457-6676 or info@pdf.org.  To read more about deep brain stimulation, view PDF's eight-page fact sheet, Deep Brain Stimulation at www.pdf.org/pdf/fs_long_understanding_dbs_2012.pdf.

Read PDF Fact Sheet: Deep Brain Stimulation

Source Date: May 31 2013
Source Publication: FDA
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