BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS DR

    MDR report key: 3210590 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03545
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 13, 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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED IN A HOSPITAL EMERGENCY ROOM AFTER RECEIVING 3 SHOCKS INAPPROPRIATELY DURING PHYSICAL ACTIVITIES. IT WAS FOUND THE FAST RHYTHM WAS CAUSED BY PHYSICAL ACTIVITY AND WAS NOT COUNTED AS NORMAL RHYTHM. PROGRAMMING CHANGE WERE RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310040 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR