Federal health officials are warning that problems with caps on Medtronic Deep Brain Stimulation (DBS) leads could cause severe injury or death.
On May 2, the FDA classified a warning sent out by Medtronic regarding its Deep Brain Stimulation lead wires as a Class I medical device recall, suggesting that the agency believes problems with the lead caps are likely to result in severe injury or death. However, there have been no injuries reported to date.
The Urgent Medical Device Correction was originally sent out by Medtronic in February. According to the company, health care professionals have warned that DBS leads may be damaged due to twisting of the connector within the lead cap while a surgical procedure is underway. The caps are sometimes used to temporarily protect the end of a deep brain stimulation lead after it has been implanted, but not always.
Medtronic’s original communication stated that lead damage could result in the need for lead replacement or patients not getting the optimal DBS therapy. However, it did not warn of a risk of severe injury or death. The company says it has addressed the problem through a manufacturing change, which is now being reviewed by the FDA for approval.
Deep brain stimulation is similar to a pacemaker, but used in a patient’s brain. The leads deliver electrical pulses to precise locations in the brain to treat dystonia and Parkinson’s disease, as well as refractory epilepsy.
Medtronic advises customers who have experienced malfunctions or adverse events related to DBS therapy to contact the Medtronic Neuromodulation Technical Services at (800) 707-0933 and to also report the events to the FDA’s MedWatch Program.