Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Loss of Range of Motion (2032)
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Event Date 05/15/2017 |
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 the patient was unable to move his right leg and as a result, the patient was in a wheelchair.Scans indicated the presence of a hematoma.Subsequently, the hematoma was removed on (b)(6) 2017.
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Event Description
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Follow-up identified the patient's system was explanted (at an unknown date) due to the hematoma.The patient has since been re-implanted.
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Event Description
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Follow-up identified the patient's lead was explanted on (b)(6) 2017.In addition, the patient received a new implant on (b)(6) 2017.
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Search Alerts/Recalls
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