Model Number 3664 |
Device Problems
Failure to Disconnect (2541); Separation Failure (2547); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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Related manufacturer report number: 1627487-2023-00640, 1627487-2023-00642.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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Date of event is estimated.
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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 ipg.X-ray analysis revealed a lead terminal end contact (non-functioning) was stuck in the set screw block for port 1 (channels 1-4) and for port 2 (channels 5-8).The detached lead terminal end contacts occurred during the lead revision procedure.As received, the set screw for port 1 and port 2 were fully engaged.Normal operation of the set screws for port 1 and 2 was observed.However, further testing could not be performed since the lead terminal end contacts could not be removed from ports 1 and 2.
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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 2.
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Search Alerts/Recalls
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