BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 1013378 · Received March 10, 2008

    Report

    Report Number
    2649622-2008-00962
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    June 22, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    UT
    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 80 YR Other| R 4076 IMPLANTABLE PACING LEAD| E2DR21 IMPLANTABLE PULSE GENERATOR