BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS DR

    MDR report key: 2242968 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06642
    Event Type
    Injury
    Date Received
    September 11, 2011
    Date of Event
    June 9, 2011
    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
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE ANOMALY REPORTED IN THE FIELD WAS CONFIRMED IN THE LABORATORY. THE ROOT CAUSE IS BELIEVED TO BE DUE TO A LEAD INSULATION BREACH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SEVERAL ABORTED THERAPIES DUE TO POSSIBLE OUTPUT CIRCUIT DAMAGE. THE HVLI TREND SHOWED A STEADY DECREASE IN IMPEDANCE. THE DEVICE WAS EXPLANTED AND REPLACED.

    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 57 YR Required Intervention (B)(4)