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Open, Classified

Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

FDA Recall Z-1691-2024 · Posted 2024-04-26

Recalling FirmMedtronic Neuromodulation
Recall StatusOpen, Classified
Product CodeLGW
Date Initiated2024-03-28
Product Quantity1 unit

Reason for Recall

inability to reprogram one device

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

International distribution in the country of UK.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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