Model Number 3660 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/19/2018 |
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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Related manufacturer reference number: 1627487-2019-08756, related manufacturer reference number: 1627487-2019-08757.It was reported that the extension tails were not in the header of the ipg correctly causing them to be difficult to insert.The physician was eventually able to properly insert extensions.
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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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Event Description
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It was reported that the patient underwent revision surgery on(b)(6) 2019 to reposition extensions.Therapy was restored postoperatively.
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Search Alerts/Recalls
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