BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS DR

    MDR report key: 3872910 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11811
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 19, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY. THE DEVICE IMAGE WAS REVIEWED AND THE RESET WAS FOUND TO HAVE BEEN CAUSED BY PARITY ERRORS AND A WATCHDOG ERROR. THE DEVICE WAS TESTED ON THE BENCH AND AUTOMATED TEST EQUIPMENT, AND NO ANOMALY WAS FOUND. THE CAUSE OF THE PARITY AND WATCHDOG ERRORS COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. THE PHYSICIAN NOTICED THAT THE DEVICE WAS IN BACKUP VVI AND WITH NO DEFIB THERAPIES AVAILABLE. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE DEVICE. THE PATIENT CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349490 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention