BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS DR

    MDR report key: 3791007 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10338
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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

    THE REPORTED INAPPROPRIATE HV THERAPY WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF STORED EGMS. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA (B)(4) THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO ATRIAL FLUTTER/FIBRILLATION WITH A RAPID VENTRICULAR RATE. THE DEVICE WAS NEARING ERI AND WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269122 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention