BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC DR

    MDR report key: 1073518 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02412
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    March 11, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED THE FIELD EXPERIENCE OF THE PATIENT'S RATE INCREASED TO MAX SENSOR RATE DURING A CAPACITOR MAINTENANCE WAS CONFIRMED. THE ANOMALY WAS FOUND TO BE AN ELECTRICAL "NOISE" GENERATED AS A RESULT OF THE CHARGING OF THE DEVICE'S HIGH VOLTAGE CAPACITORS. THE "NOISE" COULD BE MISINTERPRETED BY THE DEVICE'S SENSORS AS ACTIVITY IF THE SENSOR WAS PROGRAMMED ON, CAUSING A TEMPORARY INCREASE IN THE PACING RATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RATE INCREASED TO THE MAX SENSOR RATE DURING A CAPACITOR MAINTENANCE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC DR IMPLANTIBLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-235 NA

    Patients

    Seq Age Sex Outcome Treatment
    1