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Model Number 6172 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 11/17/2022 |
Event Type
Injury
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Event Description
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Related manufacturer reference: 1627487-2022-06721.It was reported the patient experienced ineffective stimulation as there was no significant improvement of symptoms (tremors mainly).The bilateral leads were determined to be placed medial at implant and the physician was not satisfied with their placement.Surgical intervention was undertaken wherein both leads were removed, and new leads were implanted bilaterally.Effective therapy was restored.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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