BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSITE LV

    MDR report key: 2083625 · Received May 10, 2011

    Report

    Report Number
    2017865-2011-02522
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    February 1, 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 Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THE INSULATION WAS ABRADED FROM THE INSIDE OUT FROM 71.2 CM TO 72.5 CM FROM THE CONNECTOR PIN. THE PROXIMAL CABLES WERE EXPOSED BUT NOT ABRADED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LEAD REVISION EXPOSED WIRES WERE NOTED AT THE DISTAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1056T/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention