BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUARTET

    MDR report key: 4231336 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18118
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 2, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEAD REVISION PROCEDURE, THE GUIDEWIRE COULD NOT BE INSERTED INTO THE LEFT VENTRICULAR LEAD. THE LEAD WAS EXPLANTED AND REPLACED. AFTER THE PROCEDURE THE PATIENT WAS IN STABLE CONDITION AND WAS RELEASED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714988 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR