Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Inadequate Pain Relief (2388)
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Event Date 05/31/2018 |
Event Type
Injury
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Manufacturer Narrative
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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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Device 2 of 2: reference mfr.Report: 1627487-2018-05935.It was reported the patient experienced ineffective stimulation despite reprogramming.The patient had two falls several months ago.A drg trial is planned at a future date.
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Event Description
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Device 2 of 2: reference mfr.Report: 1627487-2018-05935.
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Event Description
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Device 2 of 2: reference mfr.Report: 1627487-2018-05935.Follow-up identified the patient underwent a drg trial on (b)(6) 2018 which yielded positive results.The plan is to undergo a permanent drg procedure.
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Event Description
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Device 2 of 2 : reference mfr.Report: 1627487-2018-05935.Follow-up identified the patient underwent a drg system implant on (b)(6) 2018.The patient has effective stimulation following the procedure.No intervention was performed on the reported scs system.
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Search Alerts/Recalls
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