Model Number 3799 |
Device Problem
Temperature Problem (3022)
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Patient Problems
Erythema (1840); Pain (1994); Burning Sensation (2146)
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Event Date 11/05/2015 |
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 discomfort due to burning sensation at the ipg site while charging and with stimulation on.Also the ipg site appeared red and warm.The patient received antibiotics for few weeks and the physician declined the possibility of infection.No additional information is available at this time.
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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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Further follow up identified the scs system was explanted.
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Search Alerts/Recalls
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