BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS DR

    MDR report key: 3090104 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01276
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    January 10, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED INAPPROPRIATE THERAPY WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF STORED ELECTROGRAMS. THE CAUSE OF THE FIELD REPORTED INAPPROPRIATE THERAPY WAS FOUND TO BE T-WAVE OVERSENSING DUE TO SMALL R-WAVES CAUSED BY PATIENT PHYSIOLOGY. THE DEVICE WAS TESTED ON THE BENCH AND WAS FOUND TO BE NORMAL. NO DEVICE ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC FOR FOLLOW-UP. REVIEW OF THE EGMS REVEALED INAPPROPRIATE THERAPY DUE TO POST SENSE T-WAVE OVERSENSING. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191564 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention