BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 1955331 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00589
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 17, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED RESET WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A POWER ON RESET DUE TO A LOW BATTERY VOLTAGE. BASED ON BATTERY USAGE, THE DEVICE MET THE EXPECTED LONGEVITY. THE PACING LEAD IMPEDANCE TREND DATA INDICATED THE LEAD IMPEDANCE HAD DECREASED FROM HISTORIC LEVELS, AND IT IS BELIEVED THE RV LEAD IS DAMAGED OR THERE WAS AN INTERMITTENT CONNECTION ISSUE.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR AN ABLATION. THE PATIENT RECEIVED THERAPY. WHEN THE DEVICE WAS INTERROGATED,THE DEVICE PRESENTED IN HW RESET WITH BVVI PACING AND NO DEFIB FUNCTION. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-343 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention