—#201304

Product

A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.

Why it was recalled

When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Only one of the two consignees received the notification since one of the consignees independently updated their tablet. On 6/22/2023, the notification dated June 2023 was issued to the consignee via visit by the sales representative. The notification described the issue and provided required actions which included: (1) Update the A901 Comm Manager application to version 1.0.1239 on the clinician programmer (tablet), serial #NPL3011706, using the instructions listed in Appendix A, Updating Clinician Programmer Software; (2) Complete the Customer Confirmation Form enclosed with the letter acknowledging that the consignee has received this information; and (3) Share this notice with all those who need to be aware of the issue within the organization and maintain a copy of it in the records.

Recalling firm

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

Distribution

Distribution pattern: International distribution to the countries of Israel and Serbia.

Timeline

Recall initiated: 2023-06-21
Posted by FDA: 2023-07-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201304. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.