Model Number 3660 |
Device Problem
Battery Problem (2885)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388)
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Event Date 06/16/2022 |
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 that the patient lost therapy and received the end of life message for the ipg.As such, surgical intervention may take place at a later date to address the issue.
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Manufacturer Narrative
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Patient weight is estimated.An error message displaying ¿replace generator.The generator has reached the end of its service¿ when patient was trying to connect to the ipg was reported to abbott.The ipg was explanted and replaced.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 indicates that surgical intervention took place on (b)(6) 2022 wherein the ipg was explanted and replaced with a new ipg addressing the issue, reportedly, therapy was restored post op.
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Search Alerts/Recalls
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