BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS HF CRT-D

    MDR report key: 1955237 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00597
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 29, 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
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERSENSING WAS NOTED ON BOTH THE ATRIAL AND VENTRICULAR CHANNELS VIA REVIEW OF A STORED EGM. NO THERAPY WAS DELIVERED AS PATIENT RETURNED TO SINUS. NOISE WAS NOT REPRODUCIBLE WITH TESTING ON EITHER CHANNEL. DURING CHANGE OUT THE LEADS WERE TESTED. NO ANOMALIES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-366 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention