BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS DR

    MDR report key: 1223752 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03516
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 11, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE FIELD EXPERIENCE OF NO COMMUNICATION WAS CONFIRMED. NO COMMUNICATION COULD BE ESTABLISHED BETWEEN THE DEVICE AND THE WAND. THE DEVICE WAS CUT OPEN AND CRACKS WERE OBSERVED ON THE TELEMETRY CERAMIC SUBSTRATE. A JUMPER WAS CONNECTED ACROSS THE CRACK AND THE DEVICE COMMUNICATED NORMALLY ON THE BENCH. THE FIELD EVENT RESULTED FROM THE CRACKED TELEMETRY SUBSTRATE..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED AT FOLLOW-UP. IT IS NOTED THAT THE PATIENT HAS A HISTORY OF BREAST CANCER AND HAS HAD CHEMOTHERAPY AND RIGHT BREAST RECONSTRUCTIVE SURGERY. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention