Model Number 4675 |
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 04/04/2024 |
Event Type
Injury
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Event Description
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It was reported that this left ventricular (lv) lead was part of a system revision due to infection.There were no additional adverse patient effects reported.The lv lead was explanted.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, the lead was returned for analysis.The allegation against the product was not confirmed as the reported allegations of infection with sepsis were known inherent risk of device.Analysis of the returned product is not able to provide relevant information for infection-related allegations.This supplemental is being filed to capture d9: returned to manufacturer date and investigation results.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that this left ventricular (lv) lead was part of a system revision due to infection.There were no additional adverse patient effects reported.The lv lead was explanted.
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Search Alerts/Recalls
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