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.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: 1627487-2019-07465, 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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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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