BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 1954729 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00550
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 17, 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 Location
    MS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE FIELD EXPERIENCE OF AN OUTPUT ANOMALY WAS VERIFIED IN THE LABORATORY. A POLISH MARK WAS OBSERVED ON THE ICD CAN. IT IS BELEIVED THAT DURING HIGH VOLTAGE THERAPY DELIVERY, THE LEAD ARCED AND SHORTED THE HIGH VOLTAGE OUTPUT CIRCUITRY WITHIN THE ICD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT MESSAGE OF POSSIBLE OUTPUT ANOMALY WAS NOTED AFTER THE PATIENT RECEIVED AN APPROPRIATE SHOCK. THE ICD WAS EXPLANTED AND 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 61 YR Required Intervention (B)(4)