Model Number 3660 |
Device Problem
Insufficient Information (3190)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of the event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported the patients controller is displaying the message "replace generator soon".Surgical intervention may take place at a later date to address the issue.
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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 incident could not be conclusively determined.
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Event Description
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Additional information indicates the ipg was explanted and replaced to address the issue.Therapy was restored post-op.
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Search Alerts/Recalls
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