Model Number 3660 |
Device Problem
Battery Problem (2885)
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Patient Problems
Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/06/2022 |
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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It was reported the patients ipg is displaying a replace generator soon message indicating the device is nearing end of life.Surgical intervention may be pending to address the issue.The device is providing therapy.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.During processing of this complaint, attempts were made to obtain complete device and event information.
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Event Description
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Additional information was received indicating surgical intervention was undertaken wherein the ipg was explanted and replaced to address the issue.
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Search Alerts/Recalls
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