BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1991562 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02438
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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 VENTRICULAR CAPTURE MANAGEMENT (VCM) FEATURE WAS DETECTING HIGHER THRESHOLDS THAN THOSE FOUND VIA THE IN-CLINIC TESTING, AND IT WAS NOTED THAT AN IN-CLINIC VCM TEST SHOWED PRE-VENTRICULAR CONTRACTION ECTOPY OCCASIONALLY BEING ERRONEOUSLY LABELED AS LOSS OF CAPTURE. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD EXPERIENCED SMALL ATRIAL FIBRILLATION WAVES. IN ADDITION, THE PATIENT COMPLAINED OF COUGHING, WITH ABDOMINAL HEAVING. THE PATIENT FURTHER REPORTED THAT AFTER THE PHYSICIAN "MADE AN ADJUSTMENT" TO THE DEVICE, THERE ARE NOW "EPISODES" WHERE THE PATIENT CAN NOT BREATHE, WHICH LAST ABOUT 30 SECONDS, AND FEEL AS IF THE DIAPHRAGM IS BEING STIMULATED. THE DEVICE REMAINS IN USE. THE VCM FEATURE WAS REPROGRAMMED, AND THE VENTRICULAR LEAD REMAINS IN USE. THE ATRIAL LEAD SENSITIVITY WAS REPROGRAMMED, AND THE ATRIAL 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 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Life Threatening| R