BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE LV

    MDR report key: 7316781 · Received March 6, 2018

    Report

    Report Number
    2017865-2018-03173
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    February 7, 2018
    Report Date
    March 6, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO X-RAY VIEWS HAVE BEEN PROVIDED TO ST. JUDE MEDICAL, SO WE CANNOT FULLY CONFIRM THE EVENT. HOWEVER, BASED ON EVENT DESCRIPTION WE REGARD THIS AS A CASE OF EXTERNALIZED CABLES. NO FURTHER ANALYSIS CAN BE PERFORMED SINCE THE LEAD WILL NOT BE RETURNED TO ST. JUDE MEDICAL FOR ANALYSIS.

    Description of Event or Problem · 1

    DURING AN ICD REPLACEMENT, EXTERNALIZED CONDUCTORS WERE OBSERVED ON THE LEFT VENTRICULAR LEAD. ALL ELECTRICAL PARAMETERS WERE WITHIN NORMAL LIMITS SO THE LEAD REMAINS IMPLANTED. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160137 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC. 1056T 2923308

    Patients

    Seq Age Sex Outcome Treatment
    1