Model Number 3341 |
Device Problem
Disconnection (1171)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of 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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Related manufacturer reference numbers: 1627487-2020-31197, 3006705815-2020-31301.It was reported during the elective ipg replacement the leads extension were inserted in the header and in post-op the impedance was high so patient was taken back into the operating room were it was discovered that the one of the extension pull out of the ipg header the extension was reinserted resolving 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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Search Alerts/Recalls
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