BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 7151057 · Received December 28, 2017

    Report

    Report Number
    2938836-2017-35420
    Event Type
    Death
    Date Received
    December 28, 2017
    Date of Event
    December 22, 2017
    Report Date
    May 3, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AFTER THE PATIENT WAS REPORTED TO HAVE EXPIRED. UPON RECEIPT, THE DEVICE WAS ABOVE ITS ELECTIVE REPLACEMENT INDICATOR (ERI). TESTS MEASURING IMPEDANCE, LEAD CONNECTOR INTEGRITY, AND HIGH VOLTAGE OUTPUT WERE PERFORMED AND ALL WERE DETERMINED TO BE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY FROM AN UNKNOWN CAUSE. ANALYSIS OF SESSION RECORDS FROM THE DEVICE SHOWED THAT THE PATIENT HAD EXPERIENCE NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) AND REVEALED NO SIGN OF DEVICE MALFUNCTION. THERE IS NO KNOWN RELATIONSHIP BETWEEN THE CAUSE OF DEATH AND ANY OF THE IMPLANTED DEVICES. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED. RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2017-36675, 2938836-2017-35421, 2017865-2017-36677.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932425 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CD3371-40Q 4119143

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death 1458Q/75, (B)(4)| 1999/52, (B)(4)| 7122Q/58, (B)(4)