BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 3790938 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10412
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 18, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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 FIELD EVENT OF AN OUTPUT ANOMALY WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT, AND THE HIGH VOLTAGE OUTPUT TRANSISTORS WERE FOUND TO BE DAMAGED. THE CAUSE OF THE DAMAGED OUTPUT TRANSISTORS COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT DUE TO NORMAL ERI, THE DEVICE REGISTERED AN OUTPUT ANOMALY DURING DFT TESTING, AND THE PATIENT WAS RESCUED WITH EXTERNAL DEFIBRILLATION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267465 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention 1581/65, (B)(4)