Model Number 3789 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Date 02/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.Date of event is estimated.
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Event Description
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It was reported the patient experienced warm sensations at the ipg site while charging.Surgical intervention may be pending.
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Manufacturer Narrative
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A patient experienced warm sensations at the ipg site while charging was reported to abbott.As a result, the ipg was explanted and replaced.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 event could not be conclusively determined.
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Event Description
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It was reported that the patient underwent surgical intervention on (b)(6) 2020 wherein the scs ipg was explanted and replaced to address the issue.
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Search Alerts/Recalls
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