BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC II HF CRT-D

    MDR report key: 1050723 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01680
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    January 30, 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 Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED WITH THE PROGRAMMER. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC II HF CRT-D NO BNCN FOUND FOR THIS DEVICE NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-355 NA

    Patients

    Seq Age Sex Outcome Treatment
    1