BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 1083414 · Received July 25, 2008

    Report

    Report Number
    2182208-2008-00251
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4965 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention 4965 IMPLANTABLE PACING LEAD| KDR921 IMPLANTABLE PULSE GENERATOR