BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 3051065 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04736
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AT GENERATOR CHANGE THE VENTRICULAR LEAD IMPEDANCE WAS LOW AND THE THRESHOLD WAS HIGH IN THE BIPOLAR CONFIGURATION.WHEN THE LEAD WAS TESTED UNIPOLAR BOTH THE IMPEDANCE AND THRESHOLD RESULTS WERE ACCEPTABLE. THE LEAD REMAINS IN USE IN UNIPOLAR POLARITY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153600 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR 8330 IMPLANTABLE PACEMAKER