Model Number 3660 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Date 03/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported the patient was experiencing heating at ipg pocket site.In turn, surgical intervention was undertaken wherein the ipg was explanted and replaced.Ipg pocket was repositioned and it addressed 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 incident could not be conclusively determined.
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Search Alerts/Recalls
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