BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELLENCE+

    MDR report key: 2123740 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-08002
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 LEAD EXPERIENCED HIGH THRESHOLD. THE LEAD IS STILL 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 EXCELLENCE+ IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. IMD49 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other 528 IMPLANTABLE PACEMAKER/CARDIO/DEFIB