Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. Medtronic, Inc., 710 Med

FDA device recall Z-0290-2007 · posted 2006-12-19 · Terminated

Recall details

Recalling firm

Medtronic Neurological

Reason for recall

A subset of Kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. Sudden cessation of therapy can result in the immediate return or worsening of underlying symptoms due to the progression of the disease state.

Action taken

Letter dated July 2006. Recommendations were made to Health Care Providers of the following: 1.Consider the potential for this anomaly if your patient present with a device in a POR state. 2. Consider informing your patients of this risk and advise them to seek attention immediately if they experience a return of pre-implant or more advanced symptoms. 3. Determine whether device replacement is warranted based upon consultation with your patient, review of the patient''s medical history and consideration of the relative risks of abrupt cessation of stimulation versus the risk of a device replacement surgical procedure. 4. Report any malfunction, removal and replacement to Medtronic and FDA suing the medical device reporting system. 5. Acknowledge this communication using the reply form enclosed.

Root cause

Other

Status

Terminated

Product code

MHY

Quantity affected

6726 devices

Distribution

Worldwide, including USA, Puerto Rico, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Israel, Ital

Date initiated

2006-07-19

Date posted

2006-12-19

Date terminated

2007-04-18

Location

Minneapolis, MN