BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENTITY XL DR

    MDR report key: 1073285 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02084
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 7, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    Z2977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR WAS IN BACK-UP MODE. THE DEVICE EXHIBITED ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A VOLTAGE OF 2.30 V. AFTER DOWNLOADING THE PRODUCT CODE AND REPLACING THE BATTERY, NORMAL FUNCTION ENSUED, HOWEVER MEASURED BATTERY DATA WAS LOST WHEN THE BATTERY VOLTAGE WAS REDUCED TO 2.28 V. THIS WAS DUE TO A DISCREPANT INTEGRATED CIRCUIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE NO MEASURED DATA OR DIAGNOSTICS SHOWING. REBOOTING, USING ANOTHER PROGRAMMER, DOWNLOADING, UPDATING AND CLEARING DATA WERE ALL UNSUCCESSFULLY ATTEMPTED. THE DEVICE WAS NOT AT ELECTIVE REPLACEMENT INDICATOR (ERI), BUT THE PATIENT WAS THERE FOR A BATTERY CHANGEOUT, DUE TO THE DIAGNOSTIC ANOMALY. SO THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENTITY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5376 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention