FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
- Recall number
- Z-1691-2024
- Recalling firm
- Medtronic Neuromodulation
- Product
- Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
- Status
- Open, Classified
- Initiated
- 2024-03-28
- Posted
- 2024-04-26
- Terminated
- not on file
- Reason
- inability to reprogram one device
- Root cause
- Under Investigation by firm
- Action
- Medtronic issued an URGENT FIELD SAFETY NOTICE to its sole consignee on 03/28/2024 via via an in-person delivery of the customer letter by the Technical Services Representative. The notice explained the issue and risk of resetting the device. Also included were trouble shooting steps and a factory reset to be initiated by Medtronic upon the implanting physicians' authorization.
- Quantity
- 1 unit
- Distribution
- International distribution in the country of UK.
- Lot, serial or model codes
- UDI/DI 00643169781719
- 510(k) numbers
- not on file
- PMA numbers
- ["P840001"]
- Product code
- LGW
- 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