Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Weakness (2145)
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Event Date 05/02/2018 |
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.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.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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It was reported the patient experienced leg weakness and urinary incontinence since the implantation of the scs system.The patient was hospitalized due to the issue.The patient's leg weakness has resolved, however the urinary continence remains.Reprogramming is planned to further evaluate the issue.
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Event Description
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Follow-up identified reprogramming provided effective pain relief.The patient was reportedly doing well as of (b)(6) 2018.
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Search Alerts/Recalls
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