Model Number 3799 |
Device Problem
Temperature Problem (3022)
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Patient Problems
Pain (1994); Burning Sensation (2146)
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Event Date 07/17/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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It was reported, the patient ((b)(6)) experienced pain at the ipg site due to pocket heating while charging.A sjm representative tried troubleshooting and replacement of charger to no avail.Consequently, the ipg was explanted and replaced.
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Manufacturer Narrative
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Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Additional information received identified the issue of pocket heating did not resolve with the replacement of ipg.Issue persisted after re-implant will be analysed on a different record.
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Search Alerts/Recalls
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