BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSITE LV

    MDR report key: 3923160 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14496
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1482
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND TWO INSULATION ABRASIONS BREACHING RING ELECTRODE CABLE LUMEN AT 81.3 CM TO 81.5 CM AND AT 81.8 CM TO 81.9 CM FROM THE CONNECTOR PIN. ONE OF THE RING ELECTRODE CABLE WAS ABRADED AT 80.0 CM TO 80.1 CM FROM CONNECTOR PIN AND THE INNER COIL WAS EXPOSED AT THIS REGION CAUSING SHORTING.

    Description of Event or Problem · 1

    NEW INFORMATION ON 8/21/2014, NOTED THAT THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. THE PATIENT HAD AN ALERT FOR LOW LEAD IMPEDANCE ON THE LEFT VENTRICLE LEAD. THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401870 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1056T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention