Model Number 3716 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Pain (1994)
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Event Date 01/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.Date of explant is unknown.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 that patient experienced heating at the ipg pocket site.As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced.
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain patient¿s weight.Further information was requested but not received.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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Additional information received identified that the issue was resolved.
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Search Alerts/Recalls
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