BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 3802516 · Received May 9, 2014

    Report

    Report Number
    2017865-2014-13751
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    February 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED EXTERNAL DEFIBRILLATION SHOCKS FOR AN EPISODE OF VENTRICULAR FIBRILLATION ARREST. PARAMEDICS WERE UNAWARE THAT THE DEVICE WAS IMPLANTED ON THE PATIENTS RIGHT SIDE AND THE SHOCKS WERE DELIVERED DIRECTLY OVER THE DEVICE. UPON INTERROGATION, THE DEVICE EXHIBITED LOSS OF CAPTURE AND A SENSING ANOMALY. A HIGH VENTRICULAR RATE EPISODE WAS RECORDED BY THE DEVICE. THE DEVICE WAS REPROGRAMMED. UPON RESTORATION OF VENTRICULAR CAPTURE, PAUSE DEPENDANT ECTOPY CEASED. THE PHYSICIAN BELIEVED THAT THE LOSS OF CAPTURE AND HIGH SENSOR INDICATED RATE WERE DUE TO MYOCARDIAL ISCHEMIA AND THAT THERE IS NO ALLEGED MALFUNCTION ON THE DEVICE OR THE LEADS. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281828 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM2212 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR