BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 1792358 · Received August 11, 2010

    Report

    Report Number
    2182208-2010-00445
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    May 5, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 THAT THE RIGHT VENTRICULAR LEAD SHOWED A LOSS OF CAPTURE. THE LEAD HAS BEEN IMPLANTED FOR APPROXIMATELY FOUR WEEKS. THE LEAD REMAINS IMPLANTED AND NO REPORTED PATIENT COMPLICATIONS ARE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 6721M IMPLANTABLE TACHY LEAD| 4098 IMPLANTABLE PACING LEAD| 6721L IMPLANTABLE TACHY LEAD