BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 1896681 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04854
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 25, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER EXPERIENCING A DEFIBRILLATION SHOCK. X-RAY REVEALED LEAD DISLODGEMENT. THE LEAD WAS REMOVED. THE PHYSI CIAN FELT THAT IT WAS A PATIENT COMPLIANCE ISSUE RATHER THAN A DEVICE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 64 YR Required Intervention (B)(4)