BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 3923922 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14863
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    March 17, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1483
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: FINAL ANALYSIS FOUND THE LEAD WAS RETURNED IN THREE PIECES. INSULATION ABRASION BREACHING THE RING ELECTRODE CABLE LUMEN WAS NOTED AT 4.9 CM TO 6.0 CM FROM THE DISTAL TIP. X-RAY OF THE S CURVE FOUND FRACTURED RING ELECTRODE CABLES AT 3.3 CM TO 4.2 CM AND 4.9 CM TO 6.0 CM FROM DISTAL TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICLE LEAD EXHIBITED INSULATION ABRASION. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401346 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1156T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention