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Recall Observatory FDA recall evidence

Device product

Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

Z-1691-2024

March 28, 2024

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 94338
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1691-2024

Official wording

Reason: inability to reprogram one device

Code information: UDI/DI 00643169781719

Distribution pattern: International distribution in the country of UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    inability to reprogram one device