Recall Z-1580-2013 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The drug is stored in the pump reservoir. Per a programmed prescription, the drug moves from the pump reservoir, th
| Date | Jun 25, 2013 (initiated Jun 3, 2013) |
| Status | Terminated |
| Reason | Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und |
| Root cause | Device Design |
| Action | Medtronic sent an Urgent Medical Device Correction letter dated May 2013, to all affected customers. The letter described the issue of the pump's potentially shorting, how to identify if a pump is affected, and provided ongoing patient management recommendations. The Medtronic Rep would complete a Physician Notification Confirmation Form. A copy of the recall notification letter and the completed Confirmation Form is to be left with the physician. Customers with questions were instructed to call 1-800-707-0933. For questions regarding this recall call 763-526-9738. |
| Quantity | 261,109 total devices estimated implanted Worldwide |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.