BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS HF

    MDR report key: 2905164 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00615
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    January 28, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P960013
    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.

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION COULD NOT BE CONFIRMED IN THE LABORATORY. BASED ON PROGRAMMED SETTINGS AND USING DEVICE DATA, A LONGEVITY CALCULATION WAS PERFORMED AND THE BATTERY WAS WITHIN THE NORMAL LONGEVITY ESTIMATES. DEVICE FUNCTION WAS NORMAL WHEN TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD DISLODGED THREE TIMES. THE LEAD WAS REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10627 ATLAS II PLUS HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-367 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention (B)(4)