Model Number 3286 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Type
Injury
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Manufacturer Narrative
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Date of event is unknown.Date of explant is estimated.During processing of this complaint, attempts were made to obtain complete patient information.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference numbers: 1627487-2020-23382, 1627487-2020-23383.It was reported that the patient experienced uncomfortable stimulation.In turn, the patient underwent surgical intervention wherein the entire scs system was explanted (estimated date: (b)(6) 2019).
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain complete patient information.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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