Model Number 3660 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is estimated.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 that the patient saw the elective replacement indicator (eri) message for their ipg.It is unknown if the message displayed prematurely or not.The device is still providing therapy.
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Manufacturer Narrative
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A4 patient weight added to the report.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 received stated that patient underwent surgical intervention wherein the ipg was explanted and replaced, resolving the issue.
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Search Alerts/Recalls
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