BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 1791817 · Received August 10, 2010

    Report

    Report Number
    2182208-2010-00414
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    August 20, 2007
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD WAS REPLACED DUE TO NO CAPTURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention KDR921 IMPLANTABLE PULSE GENERATOR| 4965 IMPLANTABLE PACING LEAD