BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE LV

    MDR report key: 3781695 · Received April 30, 2014

    Report

    Report Number
    2017865-2014-11974
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    July 27, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    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 LEFT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLDS, THE DEVICE WAS REPROGRAMMED TO PACE RIGHT VENTRICULAR ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260375 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1056T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR (B)(4)