Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Range of Motion (2032); Bowel Perforation (2668)
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Event Date 08/13/2016 |
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.Udi(di): (b)(4).
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Event Description
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It was reported the patient experienced loss of sensation in her legs and suffered from a bloated stomach.Subsequently, the patient's system was explanted on (b)(6) 2016 during which the physician removed a blood clot which was pushing down on the spinal canal.
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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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Upon further review, it was reported the patient passed away (reference mfr.Report: 1627487-2016-04733).The patient never regained feeling in her legs.Additionally, the patient received unsuccessful treatment for constipation.
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Search Alerts/Recalls
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