Model Number 3716 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Weight Changes (2607)
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Event Date 04/21/2015 |
Event Type
Injury
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Event Description
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It was reported, the patient experienced pain at her scs ipg pocket site due to the scs ipg migration as a result of losing a significant amount of weight.The scs ipg was explanted, replaced with a different model and the pocket site was relocated.
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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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Additional information received identified the issue resolved with the surgical intervention.
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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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