BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 13112256 · Received December 29, 2021

    Report

    Report Number
    2017865-2021-40325
    Event Type
    Death
    Date Received
    December 29, 2021
    Date of Event
    December 1, 2021
    Report Date
    March 23, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734508377
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED DUE TO A PATIENT DEATH. INTERROGATION OF THE DEVICE REVEALED THE DEVICE WAS ABOVE THE ELECTIVE REPLACEMENT INDICATOR WHEN RECEIVED. PACING, SENSING, IMPEDANCE, HV OUTPUT, PATIENT NOTIFIER WAS TESTED AND NO ANOMALY WAS DETECTED. THE DEVICE WAS TESTED ON THE ATE STATION AND NO ANOMALY WAS DETECTED. NO DEVICE MALFUNCTION WAS DETECTED.

    Description of Event or Problem · 0

    NEW INFORMATION NOTED THAT THE PATIENT DEATH FROM A VF EVENT WAS LIKELY DUE TO CORONARY BLOCKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS DECEASED. UPON INTERROGATION, IT WAS FOUND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAILED TO DELIVER THERAPY FOR A VENTRICULAR FIBRILLATION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011080 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000099429 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Death OPTISURE MRI| QUARTET| TENDRIL