BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II HF CRT-D

    MDR report key: 1895853 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04788
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 27, 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
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LOSS OF COMMUNICATION WAS CONFIRMED IN THE LABORATORY. DEVICE SETTING INFORMATION WAS REQUESTED BUT NO DATA WAS RECEIVED. BASED ON STANDARD DEVICE SETTINGS, THE DEVICE MET THE EXPECTED LONGEVITY. NO HIGH CURRENT DRAIN SOURCES WERE FOUND DURING BENCH AND AUTOMATED ELECTRICAL TESTING. THE BATTERY WAS SENT TO THE VENDOR FOR FURTHER ANALYSIS. NO ANOMALIES WERE FOUND THAT WOULD CAUSE INTERNAL LOADING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE PATIENT FELT POORLY IN RECENT WEEKS WHICH PROMPTED HIM TO HAVE A DEVICE CHECK. 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 57 YR Required Intervention