BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY ADX XL DR

    MDR report key: 1223878 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03422
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 29, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE PULSE GENERATOR TO BE IN BACK-UP MODE DUE TO MULTIPLE FLIPPED BITS. THE PRODUCT CODE COULD NOT BE DOWNLOADED WITH ORIGINAL BATTERY. THE BATTERY WAS AT END-OF-LIFE WITH A VOLTAGE OF 2.10 V. AFTER REPLACING THE BATTERY, AND DOWNLOADING THE PRODUCT CODE, THE DEVICE FUNCTIONED NORMALLY.

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR COULD NOT BE INTERROGATED. LOSS OF CAPTURE WAS NOTED. THE DEVICE WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention