BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANALYST ACCEL VR, 36J

    MDR report key: 6126695 · Received November 23, 2016

    Report

    Report Number
    2938836-2016-14788
    Event Type
    Death
    Date Received
    November 23, 2016
    Report Date
    October 25, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED FIELD EVENT OF BACKUP VVI (BVVI) WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE NOTED THERE WERE 31 ABORTED HV THERAPIES DUE TO AN OUTPUT ANOMALY. VISUAL INSPECTION NOTED AN ARC MARK CONTAINING LEAD MATERIAL ON THE DEVICE CAN. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TESTING EQUIPMENT, AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE BVVI AND OUTPUT ANOMALY COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED A SERIOUS OF CARDIAC EVENTS AND EXPIRED. THE CAUSE OF DEATH WAS SUBSEQUENTLY CONFIRMED AS VENTRICULAR FIBRILLATION AND CARDIOMYOPATHY. THE PATIENT EXPIRED AS A RESULT OF ALLEGEDLY FAILURE OF THE ICD SYSTEM TO DELIVER SHOCK DUE TO AN INSULATION ABRASION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776800 ANALYST ACCEL VR, 36J IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD1219-36 2917204

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4)