BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 1955222 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00552
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 15, 2010
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED RESET WAS CONFIRMED. ANALYSIS FOUND THE DEVICE IN BACKUP VVI MODE UPON RECEIPT. THE DEVICE IMAGE WAS RETRIEVED AND ANALYZED. IT WAS NOTED THAT THE DEVICE HAD A POWER ON RESET (POR) ON (B)(6) 2010 WHILE DELIVERING HV THERAPY. THE RESET WAS CLEARED AND THE DEVICE WAS EXTENSIVELY TESTED. NO ANOMALIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED RESET COULD NOT BE CONCLUSIVELY DETERMINED. IT IS BELIEVED THAT A CONNECTION ISSUE WAS THE CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE DEVICE WENT INTO BACK-UP VVI MODE AFTER A WARNING MESSAGE. THE PHYSICIAN WAS PROMPTED TO RETRIEVE THE MEMORY MAP REPORT. SEVERAL ATTEMPTS WERE MADE TO CLEAR THE MESSAGE. AN ALERT MESSAGE THEN STATED THAT TACHY WAS PROGRAMMED OFF AND THE DEVICE COULD NOT BE INTERROGATED ANY FURTHER. THE POCKET WAS OPENED AND THE DEVICE WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention