Model Number MN10450-50A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Twiddlers Syndrome (2114); Inadequate Pain Relief (2388)
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Event Date 09/12/2019 |
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.
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Event Description
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Reference manufacturer report number: 1627487-2019-10941.Reference manufacturer report number: 1627487-2019-11220.It was reported that the patient's leads migrated and the patient had a system explant.Follow up identified that the patient twiddled with the ipg in the pocket causing the leads to wrap around the ipg.
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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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