BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS DR

    MDR report key: 2902583 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00447
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 23, 2012
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED SENSING ANOMALY COULD NOT BE CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH. SENSING WAS NORMAL ON BOTH THE ATRIAL AND VENTRICULAR SENSING CHANNELS. THE DEVICE WAS NORMAL AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYNCOPE EPISODE AND THE DEVICE DID NOT RECORD THE SESSION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8771 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR (B)(4)