Model Number 3788 |
Device Problems
Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 02/11/2016 |
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 has not used the system in two years and the patient needs a contraindicated procedure.Surgical intervention is planned to address the issue.
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Event Description
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It was reported the patient's ipg was explanted.
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Search Alerts/Recalls
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