Model Number 3660 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Date 12/09/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient has burning at the implant site.Surgical intervention is pending to address this issue.
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Manufacturer Narrative
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B3: event date is estimated.
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Event Description
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Additional information received reports that the patient underwent surgical intervention in which the ipg was explanted and replaced.
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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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