Model Number 3661 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Irritation (1941)
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Event Date 08/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.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 irritation at the ipg pocket site.As result, patient underwent surgical intervention wherein the ipg was explanted.The irritation resolved 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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