BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 2130124 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00861
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 THAT SINCE THE IMPLANT THE LEAD EXPERIENCED INCREASING TRUE BIPOLAR THRESHOLD. THE LEAD PACING IMPEDANCE WAS ALSO DECREASING. IT WAS QUESTIONED WHETHER THE ISSUE RELATED TO CONNECTION OR SET SCREW ISSUE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN 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. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other 7122 COMPETITOR IMPLANTABLE PACING LEAD| 2088 COMPETITOR IMPLANTABLE PACING LEAD| COMPETITOR IMPLANTABLE PACING LEAD