Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 12/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this complaint, attempts were made to obtain complete event and device 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 number: 1627487-2019-14186.Related manufacturer reference number: 1627487-2019-14188.Related manufacturer reference number: 1627487-2019-14189.Related manufacturer reference number: 1627487-2019-14192.It was reported the patient¿s entire scs system was explanted due to suspected infection.This addressed the issue.
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Manufacturer Narrative
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A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Event Description
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Related manufacturer reference number: 1627487-2019-14186; related manufacturer reference number: 1627487-2019-14188; related manufacturer reference number: 1627487-2019-14189; related manufacturer reference number: 1627487-2019-14192.
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Search Alerts/Recalls
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