BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 2240084 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05377
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 4, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED THRESHOLDS OF 7.0V AT 1.5MS. THE LEAD WAS CAPPED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention