BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATLAS II PLUS DR

    MDR report key: 1923463 · Received December 13, 2010

    Report

    Report Number
    2017865-2010-05408
    Event Type
    Death
    Date Received
    December 13, 2010
    Date of Event
    September 5, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS OF THE STORED EGMS REVEALED THAT THE DEVICE DELIVERED A HIGH VOLTAGE SHOCK INTO A LOW IMPEDANCE LOAD ON (B)(6) 2010, WHILE THE PATIENT WAS IN AN ARRHYTHMIA. THE LOW IMPEDANCE DAMAGED THE DEVICE'S HV OUTPUT CIRCUITRY. THE PATIENT'S ARRHYTHMIA WAS NOT CONVERTED AND WHEN THE DEVICE CHARGED TO DELIVER THE NEXT SHOCK AN OUTPUT CIRCUIT DAMAGE WAS DETECTED BY THE DEVICE. AN OCD ALERT OCCURRED AND NO FURTHER THERAPIES WERE AVAILABLE. THE LEAD IS BELIEVED TO BE DAMAGED.

    Description of Event or Problem · 1

    THERE WAS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. HOWEVER, ANALYSIS OF THE ICD REVEALED THAT THE LEAD WAS POSSIBLY DAMAGED.

    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 43 YR Death 7011/65, (B)(4)