A Medtronic Inc. medical device recall has been deemed a Class I by the U.S. Food and Drug Administration (FDA), its most serious designation.
The Medtronic device is used for deep brain stimulation (DBS) in patients diagnosed with Parkinson’s disease and other neurological conditions, said Bloomberg News. DBS therapy uses a surgically implanted medical device, similar to a pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain, the FDA explained. The recall was implemented because the device has a potentially life-threatening defect.
DBS lead damage is associated with the use of the lead cap provided in Medtronic DBS lead kits and dystonia therapy kits, the FDA said. DBS utilizes electrical pulses to treat Parkinson’s disease, tremors, obsessive-compulsive disorder (OCD), and dystonia (painful, involuntary muscle contractions), said Bloomberg News. Outside of the United States, the device is also used for hard-to-treat epilepsy cases.
The FDA indicated that Medtronic received reports of DBS leads being damaged due to twisting of the connector within the lead cap during the surgical procedure. The cap was actually constructed to protect the delicate electronics during insertion, Bloomberg News explained and is included in DBS lead kits and dystonia therapy kits and is sometimes used temporarily to protect the end of a DBS lead after implantation. The DBS lead cap is not used in all DBS procedures, and is not permanently implanted.
Depending on the extent of lead damage due to twisting of the connector during the placement and removal of the lead cap, lead replacement may be required or optimal therapy may not be achieved.
The FDA Class I designated is its most severe classification to the recall because of the likelihood of serious health consequences or death associated with use of the device. For its part, Medtronic, said Bloomberg News, alerted physicians about the issue in February and changed the device’s manufacturing. That change is being reviewed by the agency.
In the meantime, Medtronic issued modified instructions to physicians who may use DBS lead caps.
Should extensive damage have occurred, the wires might require replacement to ensure appropriate treatment, said Medtronic. Caps do not always lead to an adverse reaction, according to Medtronic, wrote Bloomberg News. If patients receive therapy as expected and with no adverse events, the flaw will likely not affect them, the device maker said.
Medtronic Neuromodulation Technical Services may be reached, toll-free, at 1.800.707.0933, weekdays, 7:00 a.m. to 6:00 p.m., Central Standard Time; the FDA’s MedWatch Program may be reached, online at http://www.fda.gov/MedWatch.