Model Number 3789 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Pain (1994)
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Event Date 06/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of the event is estimated.
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Event Description
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It was reported that patient experienced burning sensation at the implantable pulse generator site.A surgical intervention is anticipated in the near future.No additional information is available at this time.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Manufacturer Narrative
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A patient experienced burning sensation at the ipg site was reported to abbott.The system 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 wherein the scs ipg was explanted and replaced to address the issue.
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Search Alerts/Recalls
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