BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY DR+

    MDR report key: 1896434 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05244
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 17, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT
    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 PULSE GENERATOR TO BE IN BACK-UP VVI MODE DUE TO DEVICE BATTERY VOLTAGE BELOW END-OF-LIFE (EOL) LEVEL. THIS WAS DUE TO NORMAL BATTERY DEPLETION. AFTER REPLACING THE BATTERY AND DOWNLOADING THE PRODUCT CODE, NORMAL FUNCTION ENSUED.

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR WENT ABRUPTLY FROM ELECTIVE REPLACEMENT INDICATOR (ERI) TO END OF LIFE (EOL). THE DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY DR+ IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2360L

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention