BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY ADX DR

    MDR report key: 2240544 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05897
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 4, 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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE DEVICE IN BACK-UP MODE, THE PRODUCT CODE COULD NOT BE DOWNLOADED. THE DEVICE WAS AT END-OF-LIFE (EOL). NO INFORMATION WAS RECEIVED FROM THE FIELD REGARDING THE DEVICE SETTINGS. AFTER REPLACING THE BATTERY AND DOWNLOADING THE PRODUCT CODE, NORMAL FUNCTION ENSUED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY ADX DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5380 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention