Model Number 3219 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Paresis (1998); Ambulation Difficulties (2544)
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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.Udi(di): (b)(4).
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Event Description
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It was reported the patient had a loss of motor control and bruising in his legs after a lead revision surgery on (b)(6) 2016 (reference mfr 1627487-2016-04391 for previous lead revision).The patient was taken to the operating room and his entire scs system was explanted.The exact explant date is unknown at this time.Patient is currently recovering and has regained partial motor control in his legs.
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Manufacturer Narrative
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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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Follow up revealed the patient has regained the control of his right side.However the patient's left arm and leg are still very weak.The patient walks using a walker.A physical therapist and occupational therapist work with the patient at his home.There are no plans for additional intervention for the patient.
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Search Alerts/Recalls
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