BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 18983941 · Received March 26, 2024

    Report

    Report Number
    2017865-2024-36962
    Event Type
    Injury
    Date Received
    March 26, 2024
    Report Date
    March 26, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502887
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: PER-2024-0040656 IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR BYPASS SURGERY AND AORTIC VALVE REPLACEMENT. DURING THIS OPERATION THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) WERE DISLODGED. THE PATIENT WAS BROUGHT INTO THE SURGICAL LAB TO HAVE THE RA AND RV LEADS EXTRACTED AND REPLACED. THERE WERE NO SUSPECTED ISSUES WITH THE LEADS AND THE DISLODGEMENT WAS THOUGH BY THE PHYSICIAN TO BE DIRECTLY RELATED TO THE BYPASS SURGERY. THERE WERE NO COMPLICATIONS, AND THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985027 TENDRIL STS No Match NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 A000152619 05414734502887

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention ASSURITY MRI