Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Numbness (2415); Ambulation Difficulties (2544)
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Event Date 07/31/2017 |
Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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 experienced numbness in her legs, curling of the toes and had difficulty walking.The patient's symptoms persisted with stimulation turned off.Surgical intervention is planned to address the issue.
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Event Description
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Follow-up identified the patient underwent surgical intervention to explant the entire system.However, the patient's symptoms persisted after the explant procedure.
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Search Alerts/Recalls
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