BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP¿

    MDR report key: 15240095 · Received August 17, 2022

    Report

    Report Number
    15240095
    Event Type
    Death
    Date Received
    August 17, 2022
    Date of Event
    October 8, 2021
    Report Date
    April 12, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS IN VENTRICULAR FIBRILLATION HIS DEFIBRILLATOR DIDN'T RESPOND BECAUSE THE PATIENT HAD A FINE V-FIB. THE PATIENT EXPIRED AT HIS RESIDENCE. THE PATIENT HAD THEIR DEVICE IMPLANTED 5 YEARS AGO AT ANOTHER FACILITY; HE WAS FOLLOWED BY THE DEVICE CLINIC. THE MD HAS REVIEWED THE INTERROGATION AND ESCALATED TO THE ENGINEERS FOR ADDITIONAL REVIEW AND F/U WITH (B)(6). PER ELECTROPHYSIOLOGIST: "LOOKING AT HIS TRACINGS THE MOST LIKELY EXPLANATION IS THAT HIS UNDER SENSED RHYTHMS WERE SECONDARY LOSS OF VOLTAGE SECONDARY TO THE END STAGES OF CARDIAC FAILURE GIVEN PRIOR NORMAL LEAD MEASUREMENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239168 QUADRA ASSURA MP¿ DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER NIK ST. JUDE MEDICAL, INC. CD3369-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA Male Death