BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL SR

    MDR report key: 1896697 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05318
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 10, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PACING SPIKES WERE NOT OBSERVED WHEN THE VENTRICULAR LEAD WAS CONNECTED TO THE PULSE GENERATOR NOR WHEN THE PULSE GENERATOR WAS PLACED IN THE POCKET. THE INTRINSIC RATE WAS 40 BPM AND THE DEVICE SETTINGS VVI, 60 PPM, 3.5 V, 0.4 MS. THE PULSE GENERATOR WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHYR XL SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5620 NA

    Patients

    Seq Age Sex Outcome Treatment
    1