Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Muscle Spasm(s) (1966)
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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: 1627487-2017-07513.It was reported the patient presented to the emergency room due to leg spasms.The patient has two systems, an scs and a drg system.The leg spasms were present regardless of drg stimulation.The scs system was also turned off; however, it was not confirmed if spasms were still present after scs therapy was off.Follow-up identified surgical intervention is planned to address the issue.
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Event Description
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Device 2 of 2, reference mfr.Report: 1627487-2017-07513.Follow-up identified the patient underwent surgical intervention on (b)(6) 2017 during which the drg lead was revised (reference mfr.Report: 3008829311-2017-00826).At this time, it is unknown if any intervention was undertaken on the scs leads during the procedure.
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Event Description
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Device 2 of 2.Reference mfr.Report: 1627487-2017-07513.Follow-up identified there was no further intervention performed on the scs leads.
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Search Alerts/Recalls
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