Model Number 3788 |
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 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.(b)(4).
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Event Description
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It was reported the patient is experiencing pain at her scs ipg pocket site (date of event is unknown) due to recently losing weight.Surgical intervention will be taken at a later date to address the issue.
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Event Description
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Additional information received identified the patient's scs ipg was explanted and replaced with a different model about an inch higher and also placed deeper within pocket site.The issue resolved with the surgical intervention.
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Search Alerts/Recalls
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