BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS DR

    MDR report key: 3210768 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03541
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 8, 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
    PA
    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 PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER FEELING SHORT OF BREATH. THE DEVICE COULD NOT BE INTERROGATED. NO PACING OUTPUT WAS SEEN ON THE EKG. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309928 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention