BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 3223235 · Received July 12, 2013

    Report

    Report Number
    2017865-2013-04935
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    April 16, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1482
    Adverse Event
    Yes
    Product Problem
    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.

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED A LOSS OF CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323366 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1156T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention (B)(4)