Recall Z-0125-2014 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated for adjunctive therapy in reducing some of the symp
| Date | Oct 31, 2013 (initiated Sep 30, 2013) |
| Status | Terminated |
| Reason | Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended. |
| Root cause | Software design |
| Action | The firm, Medtronic, sent an "Urgent: Medical Device Correction" letter dated September 2013 entitled "Loss of Stimulation and Over Stimulation" to customers associated with the affected Medtronic neurostimulators. This letter described the product, problem and actions to be taken. The letter informed customers of the potential for these issues to occur and provided recommendations to significantly reduce the likelihood of the issues. The customers were instructed to avoid over discharge; if a rechargeable device becomes over discharged, contact Medtronic Patient Services at (1-800-510-6735) |
| Quantity | 38,294 |
| Distribution | Worldwide distribution: US (Nationwide) including Puerto Rico and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.