Model Number 3771 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Date 02/24/2020 |
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 the patient experienced pocket heating.As a result, surgical intervention may be pending.
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Manufacturer Narrative
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The reported event of heating sensation at the ipg site could not be confirmed.The device met the product requirement specifications for heat generation during use.Also, it passed all functional testing (bench and autotest).No root cause was found for the reported issue.
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain complete patient information.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 indicates surgical intervention was undertaken on (b)(6) 2020 wherein the ipg was explanted and replaced.Issue resolved.
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Search Alerts/Recalls
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