Recall Z-1338-2012 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug Infusion System. The System includes the SynchroMed II implantable drug infusion pump 8637-20, 8637-40, N'Vision clinical programmer 8840 and the Software application card 8870. The SynchroMed II Infusion system contains and administers prescribed drugs to a specific site inside patient body. The SynchroMed II Pu
| Date | Mar 30, 2012 (initiated Mar 12, 2012) |
| Status | Terminated |
| Reason | Medtronic has confirmed that an algorithm used in the Model 8870 application card software has resulted in nine (9) occurrences of an incorrectly displayed Schedule to replace the pump by date. It is estimated that there are more than 140,000 SynchroMed II pump implants worldwide. A patient with a pump reaching EOS prior to replacement may experience the return of underlying symptoms and/or wit |
| Root cause | Software design |
| Action | Medtronic mailed an "Urgent Medical Device Correction " letter addressed to Dear Healthcare Professional on March 12, 2012. The letter described the problem, Background, Clinical Manifestations, Recommendations, and Additional Information. To ensure there is no interruption in therapy, pump replacements should be scheduled before the ERI alarm sounds and the pump reaches its 7-year end of service. Customers were advised to forward the Urgent Medical Device Correction letter to patients whose name appears on their Pump Replacement List. Reimbursement SupportFor assistance with prior authoriza |
| Quantity | 6338 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.