BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D

    MDR report key: 3914539 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13143
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    January 31, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE ASYMPTOMATIC PATIENT PRESENTED FOR ROUTINE FOLLOW UP IT WAS DISCOVERED THAT THE DEVICE HAD DELIVERED INAPPROPRIATE HIGH VOLTAGE THERAPY DUE TO NOISE ON THE RV CHANNEL. THE NOISE COULD NOT BE REPRODUCED IN CLINIC. THE NOISE EPISODE SHOWED SIGNS OF EXTERNAL EMI. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE THERAPY RECEIVED BY THE PATIENT WAS ATP DUE TO SUSPECTED LEAD NOISE, NOT HIGH VOLTAGE. ADDITIONALLY, NEW INFORMATION NOTES THAT THE PATIENT FAINTED AND FELL DOWN AND HIT HIS HEAD. PATIENT IS SCHEDULED FOR A FOLLOW UP. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389703 UNIFY QUADRA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3249-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR (B)(4)