Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Neurological Deficit/Dysfunction (1982); Paralysis (1997)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported the patient is experiencing paralysis from the waist down on left side and altered sensations on right side of body.The patient is in a rehabilitation facility and requires the use of a walker.
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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 information identified the patient is no longer in rehab and the physician stated it will take approximately 16-months to fully recover.The patient is receiving effective stimulation.
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Search Alerts/Recalls
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