Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Muscle Weakness (1967)
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Event Date 07/20/2015 |
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 lost all sensory and motor function in both legs following his scs system implant procedure.The patient was immediately taken back into surgery and the system was explanted.Follow-up identified patient has regained approximately 80% of his functionality in both legs.The patient is currently undergoing physical therapy.
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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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Follow-up identified a sjm representative followed up with the patient, and the patient reported being back to "normal".In addition, the patient's incisions were all healed.The reported issue has been resolved.
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Search Alerts/Recalls
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