BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN RF - IS-1/DF-1/LV-1

    MDR report key: 1043195 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33444
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 8, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN RF - IS-1/DF-1/LV-1 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H245 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention THE DEVICE 6776 WAS USED DURING THE EVENT.| THE DEVICE 3120 051986 WAS USED DURING THE EVENT.| THE DEVICE 7565 WAS USED DURING THE EVENT.| THE DEVICE 7552 WAS USED DURING THE EVENT.| THE DEVICE 4518/329618 WAS IMPLANTED 30-JAN-2008| THE DEVICE 0158/172945 WAS IMPLANTED 30-JAN-2008