Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Type
Injury
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Manufacturer Narrative
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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.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# 1627487-2018-05344.It was reported (b)(6) the patient experienced some unintended leg motor stimulation.The patient underwent surgical intervention wherein one of the lead was explanted and replaced with another model to resolve the issue.Stimulation was restored post-operatively.It cannot be determined which lead was explanted.Therefore, both the leads are marked as explanted.
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Event Description
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Device 2 of 2: reference mfr.Report# 1627487-2018-05344.Additional information received clarified the issue was due to the lead migration.
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Search Alerts/Recalls
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