BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 3923945 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14868
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICLE LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401257 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1258T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention (B)(4)