BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS DR

    MDR report key: 2242402 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06637
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    June 1, 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
    NM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DURING ANALYSIS A POLISH AND ARC MARK WITH LEAD MATERIAL WAS OBSERVED ON THE CAN. THERE WAS DAMAGE TO THE HIGH VOLTAGE CIRCUITRY WHICH PREVENTED OUTPUT OF THE DEVICE. NO NOISE SIGNALS WERE NOTED ON THE STORED EGMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH AN ALERT FOR AN ABORTED THERAPY DUE TO POSSIBLE OUTPUT CIRCUIT DAMAGE. THE ICD WAS EXPLANTED AND REPLACED.

    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 70 YR Required Intervention (B)(4)