BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS DR

    MDR report key: 1955299 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00576
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 22, 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
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED ANOMALY WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS FOUND TO HAVE A BROKEN CASE GROUND WIRE INSIDE THE CAN. THE DISCONNECTION OF THIS WIRE COULD CAUSE OUT OF RANGE HV LEAD IMPEDANCE BETWEEN THE RV AND CAN. THIS RESULTED IN A POWER-ON-RESET AND REVERSION TO BACK-UP OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT FOR POSSIBLE OUTPUT DAMAGE WAS OBSERVED. AFTER INTERROGATING THE DEVICE THERE WAS ONE VT EPISODE. THE DEVICE RECOGNIZED THE VT, CHARGED AND DELIVERED A SHOCK. LEAD DAMAGE WAS SUSPECTED. HOWEVER, FLUOROSCOPY AND VISUAL INSPECTION REVEALED NO DAMAGE TO THE LEAD. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention (B)(4)