BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL SR

    MDR report key: 2983703 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01608
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 7, 2012
    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 RELIABILITY LABORATORY TECHNICIAN, (B)(4). NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND AN INTEGRATED CIRCUIT ANOMALY.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88023 ZEPHYR XL SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5620 NA

    Patients

    Seq Age Sex Outcome Treatment
    1