BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 1002422 · Received February 7, 2008

    Report

    Report Number
    2124215-2008-31886
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    May 30, 2007
    Report Date
    May 30, 2007
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4034 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention THE DEVICE 4053/416391 WAS IMPLANTED 26-APR-2006| THE DEVICE 1284/705773 WAS IMPLANTED 23-MAY-2001| THE DEVICE 1280/554047 WAS IMPLANTED 26-APR-2006| THE DEVICE 4243/407486 WAS IMPLANTED 23-MAY-2001