BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD

    MDR report key: 1072466 · Received July 10, 2008

    Report

    Report Number
    6000023-2008-00012
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 24, 2008
    Manufacturer
    MEDTRONIC, B.V.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE VDD IMPLANTABLE PACING LEAD DTB MEDTRONIC, B.V. 5032 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention E2DR01 IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD