BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II DR

    MDR report key: 2902698 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00451
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    October 2, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEAR SYNCOPAL PATIENT PRESENTED TO THE ER AFTER RECEIVING MULTIPLE SHOCKS. REVIEW OF EGMS SHOWED THAT THE PATIENT HAD BEEN EXPERIENCING AN SVT RHYTHM. A THIRD HIGH VOLTAGE SHOCK WAS INITIATED BUT WAS ABORTED. THE DEVICE AND LEAD WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9339 ATLAS II DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-265 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR (B)(4) (B)(4)