Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Paralysis (1997)
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Event Date 08/04/2017 |
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 underwent surgical intervention due to a hematoma.The physician evacuated the hematoma on the same day of the implant.The patient reported failure to move her legs 5 hours later.The patient¿s entire scs system was removed.The patient is still in icu and still unable to move her left leg.Physician fears the patient will have a permanent deficit.
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Event Description
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Follow up information identified the patient has regained some movement in her left leg and is able to walk in an aided fashion.The patient was hospitalized for one week and is now in a rehab facility.
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Event Description
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Follow up information identified the patient is showing improvement however they may always have a deficit.Patient is currently being treated in outpatient rehab.
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Search Alerts/Recalls
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