Model Number 3664 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Implant Pain (4561)
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Event Date 11/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Related manufacturer reference number: 1627487-2024-007734.It was reported that the patients ipg was causing pain at the implant site, and that the patient was experiencing shocking sensations from therapy.Surgical intervention may be taken at a later date to address the issue.
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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 event could not be conclusively determined.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.
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Event Description
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Additional information received indicates that surgical intervention was undertaken on (b)(6) 2024, where the entire system was explanted and replaced with an scs system.Therapy was restored post-op.
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Search Alerts/Recalls
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