BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 1223404 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03658
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 22, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDWARE RESET WAS CAUSED BY A DEPLETED BATTERY. IT IS BELIEVED THAT THE DEPLETION WAS NORMAL BASED ON HOW THE DEVICE WAS USED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    THERE WAS ACCELERATED BATTERY DEPLETION THAT OCCURRED IN 2008. THE CAUSE OF THE ACCELERATED BATTERY DEPLETION WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    C-CC-CD - COMPONENT DIMENSIONS (COMPONENT FIT OR ALIGNMENT) LOOSE CONNECTION TUBE/STOPCOCK AFTER OPENING PACKAGE. CONNECTION OF IV SET TO IV BAG WAS MADE, THE PRESSURE LINE WAS NOT FLUSHED WHEN THE DISCONNECTION OCCURRED..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEELING SLUGGISH. WHEN THE PATIENT PRESENTED TO THE CLINIC, HIS PULSE WAS IN THE 30S. THE DEVICE WAS FOUND TO BE IN HARDWARE RESET WITH TACHY THERAPY OFF. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-343 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention