Model Number MN20450-50A |
Device Problems
Failure to Disconnect (2541); Separation Failure (2547); Mechanical Jam (2983)
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Patient Problems
Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Related manufacturer report number: 1627487-2023-00639, 1627487-2023-00640.It was reported that the patient was experiencing loss of therapy on one lead.In turn, the patient underwent surgical intervention to address the issue.During the surgery, both leads were unable to be removed from the ipg due to both the electrodes being stuck in the ipg header.As a result, the physician pulled the leads by force and the leads were frayed.The system was explanted and replaced.Effective therapy was established post-operatively.
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Manufacturer Narrative
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The reported event of difficulty removing leads from ipg header was confirmed based on the as-received condition of the lead.Visual inspection revealed that the lead was missing the terminal end contact (non-functioning).The missing terminal end contact was stuck in the ipg header.The detached lead terminal end contact occurred during the lead revision procedure.Since the lead terminal end contact was detached, a lead placement test could not be performed.The lead passed continuity resistance and isolation testing.
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Manufacturer Narrative
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Correction: section h6 codes have been updated from additional report 1 to the correct codes.
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Manufacturer Narrative
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Correction: section h6 medical device problem code should have been "2547 - separation failure" instead of "2541 - failure to disconnect".This correction is reflected in this additional report 4.
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Search Alerts/Recalls
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