Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Neurological Deficit/Dysfunction (1982)
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Event Date 04/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.(b)(4).
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Event Description
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It was reported the patient experienced a loss of sensation and movement in his lower extremities a few hours after undergoing a surgical procedure for a paddle lead implant.The patient was taken back to the operating room where the paddle lead was removed.It was noted blood clots were found in the spine once the lead was removed.The physician removed the clots and implanted a percutaneous lead.
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Event Description
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Follow up information identified the patient is currently in a rehabilitation facility.
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Event Description
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Follow up information identified the patient is in a wheelchair and unable to walk.
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Search Alerts/Recalls
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