BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUARTET

    MDR report key: 4231341 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18130
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    August 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 EXHIBITED HIGH IMPEDANCE AND HIGH THRESHOLDS. THE LEAD WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714475 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 1458Q/86, BPP049707,