Model Number 3788 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 01/01/2019 |
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 experienced pocket heating when using the implantable pulse generator.The pocket site heats up when the stimulation is turned on within two hours of usage and therapy has to be turned off completely.Patient has stimulation turned off for the past four months due to the pocket heating issue.Surgical intervention procedure is anticipated in the near future to help resolve the issue.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 was explanted.There were no complications during the procedure.Effective therapy was restored post procedure.
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Search Alerts/Recalls
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