Model Number 3660 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Date 09/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of the 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 heating at the pocket site when stimulation is on.Surgical intervention took place wherein the ipg was explanted and replaced to address 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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