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); Weakness (2145)
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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 that experienced weakness and paralysis of their legs threes days after being implanted.Imaging was taken and confirmed that there was no hematoma.The patient underwent surgical intervention to have their lead replaced with a different model on (b)(6) 2017.
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Event Description
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Follow up revealed that the patient still has some weakness is their legs, but it is continuing to improve with physical therapy.
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Search Alerts/Recalls
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