Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Unspecified Infection (1930)
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Event Date 07/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.During processing of this complaint, attempts were made to obtain complete patient information.
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Event Description
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Related manufacturer report number: 3006705815-2020-30398, 1627487-2020-23251, 1627487-2020-23252.It was reported that the patient had an infection and an abscess that ruptured near the lead site.As a result, the patient underwent surgical intervention during which the system was explanted.
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Manufacturer Narrative
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The reported adverse event is not able to be confirmed with product testing.As received, the lead was complete but cut.The lead was returned cut as a result of the explant procedure.Microscopic inspection of the lead segments did not identify any fractures.Functional testing of the terminal and stimulation segments were performed by measuring continuity between the contacts and the end of the corresponding cut wires.Continuity of the lead body segment was measured from end to end of each wire.No opens were observed in any of the lead segments.A packaging and sterility review of the production records found no non-conformance's.
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Event Description
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Additional information received indicates that the infection had later cleared.
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Search Alerts/Recalls
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