BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 1072157 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03514
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    October 25, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4074 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| KDR901 IMPLANTABLE PULSE GENERATOR