BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 1223403 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03657
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 19, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    PMAP030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED NO COMMUNICATION COULD BE ESTABLISHED. AFTER CUT OPEN, THE BATTERY VOLTAGE MEASURED 1.14V. AN EXTERNAL POWER SUPPLY WAS APPLIED IN PARALLEL WITH THE BATTERY TO REGAIN COMMUNICATION. THE DEVICE DETECTED IN HWVVI WHEN THE BATTERY VOLTAGE SLOWLY ROSE ABOVE 1.5V. THE CAUSE OF THE LOW BATTERY VOLTAGE WAS THE EXCESSIVE CHARGES. LIFETIME DIAGNOSTICS RECORDED 102 MAXIMUM EQUIVALENTT CHARGES. THE ROOT CAUSE OF THE EXCESSIVE CHARGE COULD NOT BE DETERMINED, AS THE INITIAL STORED EGMS WERE NOT VIEWABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION OF THE DEVICE, IT WAS FOUND TO BE IN HARDWARE VVI MODE. IT WAS ALSO NOTED THAT THE PATIENT HAS A LEFT VENTRICULAR ASSIST DEVICE. THE DEVICE WAS EXPLANTED.

    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 Required Intervention