BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 2014049 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01764
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 29, 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 Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXP DATE SHOULD HAVE BEEN 31-MAR-2005 RATHER THAN 31-MAY-2005. FINAL ANALYSIS FOUND THE PULSE GENERATOR TO BE IN BACKUP MODE DUE TO MULTIPLE FLIPPED BITS. THE DEVICE WAS AT END OF LIFE (EOL). AFTER REPLACING THE BATTERY AND 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 PATIENT PRESENTED TO THE CLINIC EXPERIENCING SHORTNESS OF BREATH AND THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION WITH NO PACING SUPPORT. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY ADX XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5386 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention