Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
- Company
- Medtronic Neuromodulation
- Recall Initiated
- March 28, 2024
- Posted
- April 26, 2024
- Recall Number
- Z-1691-2024
- Quantity
- 1 unit
- Firm Location
- Minneapolis, MN
Reason for Recall
inability to reprogram one device
Distribution
International distribution in the country of UK.
Lot / Code Info
UDI/DI 00643169781719
Root Cause
Under Investigation by firm
Action Taken
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.
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