BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 656299 · Received November 16, 2005

    Report

    Report Number
    MW1037194
    Event Type
    Malfunction
    Date Received
    November 16, 2005
    Date of Event
    November 9, 2005
    Report Date
    November 9, 2005
    Manufacturer
    METRONIC, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING EVALUATION. ATRIAL SENSING AND CAPTURE SEEMED INAPPROPRIATE. ATRIAL LEAD IMPEDANCE WAS FOUND TO BE >9,999 OHMS (BIPOLAR AND UNIPOLAR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ATRIAL PACING LEAD DTB METRONIC, INC. 5076 *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other