Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Muscle Weakness (1967); Numbness (2415)
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Event Date 05/17/2017 |
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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Device 1 of 2.Reference mfr.Report# 1627487-2017-02987.It was reported the patient ((b)(4)) experienced loss of sensation and motor skills in lower extremities.Diagnostics were performed which revealed hematoma and leads were explanted.The patient underwent surgical intervention for evacuation of hematoma.Reportedly, the patient remains stable and unchanged postoperatively.
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Event Description
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Device 1 of 2 reference mfr.Report# 1627487-2017-02987.Additional information received clarified the patient has been transferred to spinal rehabilitation ward.As of
(b)(6) 2017 no sensory or motor function has been restored from t6 down, however the patient is medically stable.
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Search Alerts/Recalls
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