BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLEX LV LEAD

    MDR report key: 4863527 · Received June 23, 2015

    Report

    Report Number
    2017865-2015-08049
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 28, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT PROCEDURE, EXTERNALIZED CONDUCTORS WERE OBSERVED ON THE LEFT VENTRICULAR LEAD. ELECTRICAL TESTING FOUND VARIATIONS IN CAPTURE THRESHOLD. THE PATIENT WAS ASYMPTOMATIC. THE LEAD REMAINED IMPLANTED AND THE PATIENT WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405521 QUICKFLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1156T/75 2821510

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR