ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PRODIGY MRI IPG, 16CH, RECHARGEABLE; SCS IPG
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Model Number 3772 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burning Sensation (2146)
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Event Date 12/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.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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It was reported the patient experienced pocket heating.The heating occurred all of the time, not just while charging.As a result, surgical intervention was undertaken on (b)(6) 2020 wherein the ipg was explanted and replaced.Issue resolved.
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Search Alerts/Recalls
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