Model Number 3716 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Date 04/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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It was reported the patient experienced heating at the ipg site while charging.Surgical intervention may be pending.
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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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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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Event Description
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Additional information indicates the ipg was explanted and replaced to address the issue.
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain complete patient information.Further information was requested but not received.
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Search Alerts/Recalls
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