Model Number 3662 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 03/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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Event date is estimated.
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Event Description
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It was reported that the pc displayed the message "replace generator soon." company manufacturer reported that her system would shut off periodically and she has to go in to turn the system back on.As a result patient is awaiting surgical intervention 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 received indicated that patient underwent surgical intervention wherein the ipg was explanted and replaced.Post operatively effective therapy was restored.
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Search Alerts/Recalls
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