BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUARTET

    MDR report key: 3925874 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15281
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEFT VENTRICLE LEAD EXHIBITED HIGH IMPEDANCE AT IMPLANT, WHEN MEASURED THROUGH DEVICE. THE LEAD WAS IMPLANTED AND THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403473 QUARTET PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1458Q/92 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR