FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: SynchroMed II implantable drug infusion pump, Model 8637-40
- Recall number
- Z-1694-2017
- Recalling firm
- Medtronic Neuromodulation
- Product
- SynchroMed II implantable drug infusion pump, Model 8637-40,
- Status
- Terminated
- Initiated
- 2017-02-09
- Posted
- not on file
- Terminated
- 2018-09-04
- 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
- Lot, serial or model codes
- Serial Number NGV526743H
- 510(k) numbers
- not on file
- PMA numbers
- ["P860004S056"]
- Product code
- LKK
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28