BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSITE LV

    MDR report key: 3926225 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15520
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 20, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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 WAS EXPERIENCING HIGH CAPTURE THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405080 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1056T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention