BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 8360065 · Received February 21, 2019

    Report

    Report Number
    2938836-2019-01209
    Event Type
    Death
    Date Received
    February 21, 2019
    Date of Event
    February 8, 2019
    Report Date
    June 27, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS INTERROGATED WITH A PROGRAMMER AND THE DEVICE IMAGE WAS RETRIEVED. THE DEVICE¿S SENSING, PACING, LEAD IMPEDANCE, HIGH VOLTAGE (HV) CHARGING, HV DELIVERY, AND HV SHOCK IMPEDANCE WERE TESTED, AND THE DEVICE¿S FUNCTION WAS NORMAL. THE DEVICE HAD NOT REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) OR END OF SERVICE (EOS). A VISUAL INSPECTION WAS PERFORMED, AND BODILY FLUIDS WERE OBSERVED IN THE HEADER, NO OTHER ANOMALIES WERE OBSERVED. THE DEVICE SESSION RECORDS WERE REVIEWED BY TECHNICAL SERVICES. THE DEVICE BEHAVIOR WAS FOUND TO BE NORMAL AND THE DEVICE BEHAVED ACCORDING TO ITS PROGRAMMED SETTINGS. THE REPORTED EVENT OF INTERMITTENT UNDERSENSING AND INHIBITION OF HIGH VOLTAGE OUTPUT WAS NOT CONFIRMED. THE LOSS OF THERAPY WAS DUE TO LOW SIGNAL AMPLITUDES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DECEASED DUE TO EPISODES OF VENTRICULAR FIBRILLATION (VF) IN WHICH THE DEVICE WAS UNABLE TO TERMINATE THE ARRHYTHMIA. TECHNICAL SUPPORT WAS CONTACTED AND NOTED THAT THERE WERE FOUR EPISODES OF VF, THREE OF WHICH THE DEVICE DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY, BUT THE DEVICE DID NOT DELIVER A SHOCK IN THE FOURTH EPISODE. IT WAS SUGGESTED BY TECHNICAL SUPPORT THAT UNDERSENSING MAY HAVE LED TO THE VF NOT BEING DETECTED BECAUSE THE PATIENT¿S SIGNAL AMPLITUDES WERE VERY LOW. THE DEVICE BEHAVED ACCORDING TO ITS PROGRAMMED SETTINGS IN EACH OF THE EPISODES AND NO MALFUNCTION WAS SUSPECTED. THE DEVICE WAS EXPLANTED FOLLOWING THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152799 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3371-40QC P000057122

    Patients

    Seq Age Sex Outcome Treatment
    1 Death