Model Number 3660 |
Device Problem
Battery Problem (2885)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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Event date is unknown.
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Event Description
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It was reported that the patient was not getting adequate therapy and the ipg was inoperable.As a result, surgical intervention took place on (b)(6) 2021 wherein the ipg was explanted and replaced.
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Manufacturer Narrative
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A4 patient weight added to the report.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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Event Description
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It was reported that the patient has effective therapy post operatively.
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Search Alerts/Recalls
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