Model Number 3386 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)
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Event Date 06/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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Further information was requested but unable to obtain.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 number: 3006705815-2019-02431, related manufacturer reference number: 1627487-2019-07464, related manufacturer reference number: 1627487-2019-07466.It was reported that the patient had not used their scs system in a couple of years.As such, the scs system was explanted on (b)(6) 2019.
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Manufacturer Narrative
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Corrected data- initial reporter.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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Event Description
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New information received indicated that the scs system was explanted due to discomfort at ipg site and ineffective stimulation.
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Search Alerts/Recalls
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