Medtronic Warns of Wire Fractures with Deep Brain Stimulation (DBS) DeviceJul 6, 2016
Medtronic issued an Urgent Field Safety Notice involving its Deep Brain Stimulation (DBS) devices, which are used to treat movement disorders including Parkinson's Disease, Tremor and Dystonia. In a letter to physicians, the company said it identified 16 reports of high impedance measurements that were caused by wire fractures. Surgeons should take extra precautions to not implant wires with kinks or sharp bends. The safety alert relates to DBS pocket adaptor Models 64001 and 64002 which can be used for implantable Neurostimulators Activa PC (Model 37601) and Activa RC (Model 37612).
According to the notification, Medtronic received 16 reports of high impedance measurements, which indicate low current. Of these, 14 were discovered post-operatively and patients were forced to undergo revision surgery. In two instances, the high impedance was discovered during implantation. Medtronic emphasized device labeling specific to handling the system as described in implant manuals and system integrity checks.
An analysis revealed wire fractures located near where the adaptor wire exits the neurostimulation connector block. Medtronic said it is still investigating the cause of the wire fractures. Out of the 20,000 DBS pocket adaptors sold since 2009, Medtronic says wire fractures occurred in 0.08 percent.
Medtronic issued a similar alert in April 2015 for its DBS Extensions. The recent alert notes that the pocket adaptor conductor body is similar in design to the DBS Extensions.