BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 11678343 · Received April 16, 2021

    Report

    Report Number
    2017865-2021-15308
    Event Type
    Death
    Date Received
    April 16, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 16, 2021
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED A DECEASED PATIENT PRESENTED REMOTELY, UPON REVIEW OF MERLIN.NET TRANSMISSIONS, IT WAS OBSERVED THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAD NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING APPEARING TO BE AN AGONAL RHYTHM AS THE PATIENT WAS PASSING AWAY. THIS CAUSE RIGHT VENTRICULAR NON CAPTURE AS THE PATIENT'S HEART GAVE OUT. THE PHYSICIAN BELIEVES THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575821 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q S000079485 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 Death