BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL DR

    MDR report key: 2014068 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01793
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 6, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE PULSE GENERATOR TO BE IN BACKUP MODE. AFTER DOWNLOADING THE PRODUCT CODE, NORMAL FUNCTION ENSUED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR WAS IN BACKUP VVI OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5826 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention