Model Number 3660 |
Device Problems
Premature Discharge of Battery (1057); Use of Device Problem (1670); Temperature Problem (3022)
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Patient Problem
Pain (1994)
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Event Date 07/31/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided on the final report.Further information was requested but not received.
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Event Description
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It was reported that patient had pain and an intermittent burning sensation at the implantable pulse generator (ipg) site in her abdomen site.Patient alleged that the device came out of the ipg pocket site and that the device was not working properly.Upon diagnostic review, the ipg was determined to be inoperable due to the patient using high energy settings.A surgical intervention is anticipated in the near future.No further information is available.
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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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New information received states that the device system was explanted.No further information was available.
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Search Alerts/Recalls
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