Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Weakness (2145)
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Event Date 01/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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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.Sjm defers to the patient's physician regarding medical history.
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Event Description
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It was reported that 3 days after scs system was implanted the patient presented at the emergency room (er) experiencing right leg weakness, but no loss of motor function.The system was turned off and the er doctor ordered a ct scan to evaluate patient.
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Event Description
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Follow up information identified that patient has recovered and issue has resolved.
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Search Alerts/Recalls
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