BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 2905214 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00495
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    June 12, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD A DIFFICULT TIME ATTEMPTING TO POSITION THE LEAD INTO THE VEIN. MULTIPLE TIMES WERE TRIED WHICH RESULTED IN THE LEAD PERFORATING THE PATIENT'S VEIN. THIS WAS DUE TO THE PATIENT'S ANATOMY. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10754 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1258T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention