—#202608

Product

Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: Version 1.0.4232, UDI-DI 00763000273668.

Why it was recalled

The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.

Root cause (FDA determination)

Software design

Action the firm took

Letters dated July 2020 and flagged as "URGENT: MEDICAL DEVICE CORRECTION RESTORE CLINICIAN PROGRAMMER APPLICATION SOFTWARE UPDATE Model A71100" were issued via USPS Priority First Class Mail on 7/17/2020. The letter provided an issue summary and informed the consignee the updated version of the A71100 application was now available for download and installation for resolving the issue. The consignee was to follow the instructions provided with the letter to update the application and if assistance was needed, contact information was provided for the Technical Services team support. Once the required update is made, the action will be tracked through the firm's mobile software deployment systems and no additional reply was needed from the consignee. The letter also explained patient risk, how to identify the issue, and conditions resulting in the issue. The letter was to be shared as appropriate with those in the consignee's organization who require the information.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.

Timeline

Recall initiated: 2020-07-17
Posted by FDA: 2023-09-29
Terminated: 2024-09-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202608. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.