BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUARTET

    MDR report key: 3923519 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14801
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 16, 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
    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 PATIENT WAS EXPERIENCING DIZZINESS AND FATIGUE. DEVICE INTERROGATION REVEALED SHORT EPISODE OF VENTRICULAR TACHYCARDIA AND AN INTERMITTENT LOSS OF CAPTURE ON THE LEFT VENTRICULAR LEAD. THE LEFT VENTRICULAR SENSITIVITY AND PACING CONFIGURATION WAS REPROGRAMMED AND NORMAL FUNCTIONALITY RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400240 QUARTET PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1458Q/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR