BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 14843304 · Received June 28, 2022

    Report

    Report Number
    2017865-2022-13528
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 16, 2022
    Report Date
    June 28, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734508377
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED INTO THE CLINIC WITH MULTIPLE SECURED SENSE NON-SUSTAINED OVERSENSING (NSO) EPISODES. ALL NSO EPISODES APPEARED TO BE DUE TO POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE AND SEEMED TO HAVE CORRECTED THE ISSUE. THE PATIENT WAS STABLE THROUGHOUT THE INTERROGATION PREVIOUSLY AND POST. NO PATIENT ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736254 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000095238 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DURATA RV LEAD.| QUARTET LV LEAD.| TENDRIL RA LEAD.