Recalls / —
—#153615
Product
SynchroMed II implantable drug infusion pump, Model 8637-40,
- FDA product code
- LKK — Pump, Infusion, Implanted, Programmable
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P860004S056
- Affected lot / code info
- Serial Number NGV526743H
Why it was recalled
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 (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 7000 Central Ave, Minneapolis, Minnesota 55421-1241
Distribution
- Distribution pattern
- IL
Timeline
- Recall initiated
- 2017-02-09
- Terminated
- 2018-09-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #153615. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.