BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II HF CRT-D

    MDR report key: 1954730 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00595
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 22, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    THE REPORTED NO COMMUNICATION WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO BATTERY DEPLETION. THE DEVICE WAS CONNECTED TO AN EXTERNAL POWER SUPPLY AND COMMUNICATION WAS RE-ESTABLISHED. THE DEVICE'S FUNCTIONALITY WAS TESTED ON THE BENCH AND ON THE AUTOMATED SYSTEM. NO ANOMALIES WERE FOUND. THE BATTERY WAS RETURNED TO THE VENDOR FOR ANALYSIS. AN INTERNAL ANOMALY WAS FOUND WHICH CAUSED AN INCREASED CURRENT DRAIN AND PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. IT WAS NOTED THAT THE PATIENT HAD RECENTLY BEEN THROWN OFF A HORSE AND LANDED ON THEIR CHEST. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-365 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention