Model Number 1192 |
Device Problem
Break (1069)
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Patient Problem
Inadequate Pain Relief (2388)
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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# 1627487-2017-01179.It was reported (b)(6) the patient experienced ineffective stimulation.Diagnostics determined invalid impedances.The patient underwent surgical intervention wherein the lead and the anchor were observed broken.As a result the lead was explanted and replaced which resolved the issue.Stimulation was restored postoperatively.
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Event Description
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Device 2 of 2.Reference mfr.Report# 1627487-2017-01179.
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Search Alerts/Recalls
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