Recall Z-3043-2011 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic, Inc. - Neuromodulation
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 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 implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
| Date | Aug 29, 2011 (initiated Jul 5, 2011) |
| Status | Terminated |
| Reason | Medtronic is updating information regarding the potential for reduced battery performance that can lead to sudden loss of therapy in a small percentage of Medtronic Model 8647 SynchroMed II pumps that was communicated with Healthcare providers in July 2009. The purpose of the current communication is to provide updated information regarding the scope and occurrence of this issue and to emphasize |
| Root cause | Component design/selection |
| Action | Medtronic Neuromodulation notified physicians with an Urgent Medical Device Correction letter beginning July 05, 2011. A press was issued July 08, 2011. The letter described the issue, severity, recommendations if they notice issue, and patient management recommendations. UPDATE: in November 2011, MDT began to exchange unused pumps in inventory with pumps that contained the new battery. A letter dated November 2011 was left behind at locations in which the MDT representative swapped out the devices. |
| Quantity | 139,653 (105,002 US, 34,61 OUS) |
| Distribution | Worldwide including USA, Puerto Rico, Algeria, Aruba, Australia, Austria, Belarus, Belgium, Brazil, Chile. Colombia. Costa Rica. Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran Iraq, Ireland, Israel Italy, Jordan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.