BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE VR, DF-4 CONNECTOR

    MDR report key: 3791096 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10496
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE INDICATED THAT THE DEVICE ENTERED BACKUP VVI AND BACKUP MODE WITH DEFIBRILLATION THERAPY ENABLED (BDFO) AFTER TWO RF COMMUNICATION INTERRUPT OVERFLOWS OCCURRED WITHIN A SHORT PERIOD OF TIME AS THE DEVICE ATTEMPTED TO COMMUNICATE WITH THE REMOTE MONITORING UNIT. THE CAUSE OF THE RF COMMUNICATION INTERRUPTS WAS AN RF CHIP ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN HOSPITAL AFTER RECEIVING INAPPROPRIATE THERAPY. UPON DEVICE INTERROGATION, IT WAS OBSERVED THAT THE DEVICE WAS IN BACK UP VVI MODE. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268791 ELLIPSE VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1411-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention