BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II HF CRT-D

    MDR report key: 1073120 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02362
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    April 3, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE OBSERVED DURING ANALYSIS. NO COMMUNICATION COULD BE ESTABLISHED UPON INTERROGATION. THE DEVICE WAS OPENED FOR FURTHER ANALYSIS. A CRACKED TELEMETRY SUBSTRATE WAS FOUND. NO OTHER ANOMALIES WERE OBSERVED.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS. THE DEVICE WAS NOT IMPLANTED.

    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