Model Number 3662 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Date 08/31/2020 |
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 went to bed on a heating pad on tonic stim and now is experiencing burning at the ipg site.Surgical intervention may take place at a later date 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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Event Description
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Additional information found the burning/pain at the ipg site resolved after the patient's leads were explanted and replaced (manufacturer reference number: 3006705815-2020-31749 & manufacturer reference number: 3006705815-2020-31750).X-ray had shown the lead tails were twisted in the battery pocket.
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Search Alerts/Recalls
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