Model Number 3788 |
Device Problem
Temperature Problem (3022)
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Patient Problems
Failure of Implant (1924); Burning Sensation (2146)
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Event Date 09/30/2020 |
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 the patient was experiencing burning at the ipg site when charging and making changes with the external device.As a result, the patient underwent surgical intervention on (b)(6) 2020 to have their ipg explanted and replaced.Surgical intervention 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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