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Model Number 6372 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2023 |
Event Type
Injury
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Event Description
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It was reported that during patients ipg replacement on (b)(6) 2023, the resident accidentally fractured the extension on the left side with cautery and caused high impedances.As a result, the extension was explanted and replaced to address the issue.
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Manufacturer Narrative
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The results of the investigation are inconclusive 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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Search Alerts/Recalls
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