BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 3080151 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-01030
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    February 14, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 PATIENT PRESENTED TO CLINIC AFTER A FALL AND STATED THE DEVICE HAD BEEN STRUCK. THE PATIENT NOTED THE DEVICE HAD BECOME RED, SWOLLEN, AND WARM TO THE TOUCH. DURING THE EXAM, PUSS WAS VISUALIZED COMING FROM THE POCKET. THE PATIENT WAS HOSPITALIZED AND THE POCKET WAS DOSED WITH ANTIBIOTICS. DEVICE REMAINS IMPLANTED AND PATIENT TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181159 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention