Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 11/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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The date of event is estimated.The results, method and conclusion codes along with the investigation results will be provided in the final report.
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Event Description
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Manufacturer report reference number: 3006705815-2020-32728, 3006705815-2020-32729, 1627487-2020-47830.It was reported that the patient experienced an infection at the lead site.As a result, the patient had the system explanted to address 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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Additional information indicates patient received antibiotics.
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Search Alerts/Recalls
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