BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 1882280 · Received October 26, 2010

    Report

    Report Number
    2182208-2010-00872
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    May 28, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 4968 LEAD HAD HIGH THRESHOLDS AND NON-CAPTURE. THE 4965 LEAD WAS AN IMPLANT ATTEMPT FAILURE. NEW DEVICE AND LEAD WERE SUCCESSFULLY IMPLANTED. 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 11 YR Required Intervention 7960IB IMPLANTABLE PULSE GENERATOR