Device Problems
High impedance (1291); Difficult to Insert (1316)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/18/2019 |
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 on the final report.Further information was requested but not received.
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Event Description
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Related manufacturer reference number: 1627487-2019-07818 & 1627487-2019-07820.It was reported that the patient experienced invalid impedances.As a result, surgical intervention was taken.During the procedure, it was noted that the extension was not fully inserted into the ipg header.The physician experienced difficulty fully inserting the extension into the header.The physician elected to leave the extension as is.An additional procedure is pending.
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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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Related manufacturer reference number: 1627487-2019-07818 & 1627487-2019-07820.Surgical intervention was taken on (b)(6) 2019 to replace the ipg.During the revision it was noted that the extension was broken.As a result, the extensions were both replaced.Issue has been resolved.
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Search Alerts/Recalls
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