Model Number 3788 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Increased Sensitivity (2065); Burning Sensation (2146)
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Event Date 12/10/2014 |
Event Type
Injury
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Manufacturer Narrative
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Result: the returned ipg communicated with all lab utilities, passed functional testing and when programmed, did not display any anomalous outputs when monitored on an oscilloscope.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 experienced burning sensation at the ipg site regardless of stimulation and charging.Sjm representative confirmed the ipg being superficial and the ipg site being tender.As a result, the physician explanted the scs ipg and replaced it and also the physician enlarged the pocket to place the new ipg deeper.
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Manufacturer Narrative
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Udi (di): (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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Search Alerts/Recalls
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