BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 18754245 · Received February 21, 2024

    Report

    Report Number
    2017865-2024-33217
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    January 31, 2024
    Report Date
    February 21, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWS
    UDI-DI
    05414734502092
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALERT FOR HIGH VOLTAGE LEAD IMPEDANCE (HVLI) ABOVE THE UPPER LIMIT WAS NOTED ON A REMOTE TRANSMISSION. IT WAS NOTED THAT THE SHOCKING IMPEDANCE RV TO SVC AND CAN WAS MEASURED IN RANGE. HOWEVER, THERE HAS BEEN A GRADUAL RISE IN THE HVLI TREND, AND THE SCV TO CAN MEASUREMENT HAS INCREASED ABOVE THE UPPER LIMIT. IT WAS DISCUSSED THAT SEEING THE IMPEDANCE HAS JUST GRADUALLY RISEN INDICATES PHYSIOLOGIC CHANGES AND NOT CHANGES IN LEAD INTEGRITY. THE RV LEAD WILL BE MONITORED. THE PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575915 DURATA STS OPTIM ACTIVE FIXATION Implantable cardioverter defibrillator (non-CRT) LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7120/65 3716675 05414734502092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female QUICKSITE| TENDRIL| UNIFY ASSURA