—#186742

Product

Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 97716 Implanted Neurostimulator.

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: All serial numbers

Why it was recalled

There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Beginning 25-Mar-2021, Medtronic began notifying physicians in the US and consignees OUS via mail, email, fax, and/or personal visit by Medtronic personnel. In the US, each implanting physician was sent the medical device correction letter, the patient quick guide, and the customer confirmation form. Outside the US, the medical device correction letter, the patient quick guide, and the customer confirmation form were sent to the healthcare facilities. Additionally, on an ongoing basis, the patient quick guide will be provided with each replacement recharger.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2021-03-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186742. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.