Model Number 1192 |
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: 3006705815-2020-30397, 3006705815-2020-30398, 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.The swift-lock anchor was complete.Visual inspection did not identify any anomalies.The anchor was functionally tested and passed.A packaging and sterility review of the production records found no non-conformances.
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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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