BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR ICD, US

    MDR report key: 20790026 · Received November 27, 2024

    Report

    Report Number
    2017865-2024-71040
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 6, 2024
    Report Date
    November 26, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    UDI-DI
    05414734508094
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED VIA A REMOTED TRANSMISSION SHOWING NUN-SUSTAINED RIGHT VENTRICULAR OVER-SENSING DUE TO POST-PACED T-WAVE OVER-SENSING. PROGRAMMING CHANGES WERE DISCUSSED BUT NOT MADE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845256 FORTIFY ASSURA DR ICD, US Pulse generator, permanent, implantable NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2357-40Q A000055662 05414734508094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male DURATA| TENDRIL