Recalls / —

—#206963

Product

Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

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 00643169781719

Why it was recalled

inability to reprogram one device

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Medtronic Neuromodulation

Address

7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern

International distribution in the country of UK.

Timeline

Recall initiated

2024-03-28

Posted by FDA

2024-04-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #206963. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.