BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY AFX

    MDR report key: 2240005 · Received September 8, 2011

    Report

    Report Number
    2017865-2011-05880
    Event Type
    Injury
    Date Received
    September 8, 2011
    Date of Event
    May 27, 2011
    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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR WAS IN BACKUP VVI MODE. AFTER DOWNLOADING THE PRODUCT CODE, THE DEVICE FUNCTIONED NORMALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR WENT INTO BACKUP MODE. THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY AFX IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5346 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention