SynchroMed II implantable drug infusion pump, Model 8637-40,
This recall has been terminated (originally issued February 9, 2017).
- Company
- Medtronic Neuromodulation
- Recall Initiated
- February 9, 2017
- Terminated
- September 4, 2018
- Recall Number
- Z-1694-2017
- Quantity
- 1
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
IL
Lot / Code Info
Serial Number NGV526743H
Root Cause
Under Investigation by firm
Action Taken
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.