Recall Z-1694-2017 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
SynchroMed II implantable drug infusion pump, Model 8637-40,
| Date | Feb 9, 2017 |
| Status | Terminated |
| Reason | Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating the pump; however the pump was providing therapy. |
| Root cause | Under Investigation by firm |
| Action | A Medtronic representative visited the clinic on 2/9/2017 and corrected the SynchroMed II pump by resetting the pump memory using a SynchroMed Lab Programmer running on a Medtronic laptop with a validated protocol. Consignee was given a Medtronic "Urgent Medical Device Correction" letter dated February 8, 2017. The letter described the Issue and Actions to be taken by the consignee. For questions contact your Medtronic Representative Medtronic or Neuromodulation Technical Services at 1-800-707-0933. |
| Quantity | 1 |
| Distribution | IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.