Model Number 3664 |
Device Problem
Migration (4003)
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Patient Problems
Implant Pain (4561); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/17/2022 |
Event Type
Injury
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Event Description
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Related manufacturer reference number: 1627487-2024-07074, related manufacturer reference number: 1627487-2024-07075.It was reported that patient experienced ineffective therapy from both leads, one lead has migrated.Patient is also experiencing pain at ipg site, patients ipg had migrated from original pocket.As a result, surgical intervention may be undertaken to address the issue.
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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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Based on information obtained, decision is not reportable at this time.During the lead revision, the physician determined they would not revise the ipg.It remains implanted and functional.
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Event Description
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Additional information indicates that no surgical intervention was undertaken on the ipg, patient is no longer experiencing pain at the ipg site.
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Search Alerts/Recalls
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