Recalls / —
—#205296
Product
Model A710 Intellis Clinician Programmer Application, version 2.0.97
- FDA product code
- LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P840001
- Affected lot / code info
- UDI/DI 00763000520076, S/N: NPL1000519
Why it was recalled
Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
OUS communication to a single German consignee will be initiated via regionally approved methods beginning 19-Dec-2023. A field service technician will go to the site and reset the INS to resolve the issue.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568
Distribution
- Distribution pattern
- Germany
Timeline
- Recall initiated
- 2023-12-19
- Posted by FDA
- 2024-01-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #205296. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.