Model Number 6660 |
Device Problem
Battery Problem (2885)
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Patient Problems
Failure of Implant (1924); Movement Disorder (4412)
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Event Date 10/02/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient had a worsening of symptoms.Upon checking the dbs system it was observed that the ipg was inoperable.Surgical intervention was undertaken wherein the ipg was explanted and replaced.Effective therapy was restored postoperatively.
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Manufacturer Narrative
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Date of event is estimated.Attempts were made to obtain complete product and patient information.Further information was requested but not received.
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Manufacturer Narrative
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The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
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Search Alerts/Recalls
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