Recall Z-0694-2008 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
Medtronic Soletra 7426, Quadripolar Multi-Programmable Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA (The Medtronic Activa System in an implantable, multiprogrammable quadripolar system that delivers electrical stimulation to selected areas of the brain)
| Date | Feb 5, 2008 (initiated Oct 1, 2007) |
| Status | Terminated |
| Reason | Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy. |
| Root cause | Packaging change control |
| Action | A letter "Medtronic Urgent: Device Recall" dated October 2007 was sent to Healthcare Professionals. The letter described the device defect, product involved, root cause, probability of occurrence, recommendations and also provided information for assistance. At the time of the recall all of the product remaining in date for use (not expired) had been implanted, therefore Medtronic provided Important Patient Management Information for the implanting physicians to use in patient care and decisions regarding patient explants. |
| Quantity | 1,652 |
| Distribution | Worldwide: USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, WA, WI, WY, UT, VA, VT, and WV and countries of Australia , Austria , Belgium , Canada , Cyp |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.