BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 3923191 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14506
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 2, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGE OUT PROCEDURE, INSULATION ABRASION WAS NOTED ON THE LEFT VENTRICULAR LEAD. ELECTRICAL VALUES WERE NORMAL; THE LEAD REMAINED IMPLANTED. THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401011 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1156T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR