Model Number 6662 |
Device Problem
Battery Problem (2885)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 12/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.(implant date unknown) unique device identifier (udi #): the udi is unknown because the lot number was not provided.
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Event Description
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It was reported the patient¿s ipg approached end of life.Surgical intervention was undertaken on (b)(6) 2022 to address the issue.Ipg was explanted and replaced.Stimulation therapy was reportedly restored postoperatively.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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