Model Number 3664 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 11/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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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 recently lost weight and was experiencing pain at the implantable pulse generator (ipg) implant site.To address the issue, surgical intervention was undertaken and the ipg site was revised.No complications were noted during the procedure.
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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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