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 08/03/2018 |
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 a loss of motor function of both legs and a hematoma after the scs system was implanted.No symptoms were noted at the time of implant.The patient did not appear to have any loss of sensory function.As a result, the physician explanted the scs system.Additional information has been requested.
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Event Description
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Follow up information identified the patient was hospitalized for a day and a half, and the issue has since resolved.The scs system is not thought to have contributed to the patient¿s loss of motor function.
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Search Alerts/Recalls
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