Model Number 3286 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Skin Erosion (2075)
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Event Date 11/10/2014 |
Event Type
Injury
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Event Description
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It was reported the patient's ((b)(6)) left lead eroded through his skin.Subsequently, the physician re-buried the lead deeper in the pocket.The patient is reportedly 'doing well'.
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Event Description
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Follow-up identified the patient's skin erosion has healed.
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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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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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Search Alerts/Recalls
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