BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 3223232 · Received July 12, 2013

    Report

    Report Number
    2017865-2013-04933
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    November 29, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1483
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323217 QUICKFLEX XL LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1158T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention (B)(4)