Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Neurological Deficit/Dysfunction (1982); Weakness (2145); Numbness (2415)
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Event Date 01/30/2018 |
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.The manufacturer 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.The manufacturer 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 and weakness in the legs.Consequently, the patient underwent surgical intervention wherein the entire scs system was explanted.It was stated the patient had restored sensation and strength in legs following the procedure.The patient was admitted to the hospital for observation.
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Event Description
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Follow-up information revealed the patient remains in the hospital and should be discharged in a week or two.The patient is progressing in her ambulatory ability, but she currently needs assistance to walk and stand.However, the physician have expressed cautious optimism in her continued recovery.
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Event Description
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Follow-up information revealed the patient is now able to stand and walk independently and the patient is doing well.
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Search Alerts/Recalls
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