BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1990960 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02199
    Event Type
    Injury
    Date Received
    February 15, 2011
    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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 BY THE CLINICIAN THAT THE PATIENT WAS IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE RATE AND UNDER SENSING OCCURRING IN THE ATRIUM WITH ATRIAL FLUTTER WAVES. NO IMPROVEMENT WAS SHOWN WITH CHANGING SENSING MORE OR LESS SENSITIVE. IT WAS ALSO REPORTED THAT THE POST VENTRICULAR ATRIAL REFRACTORY PERIOD (PVARP) WAS SET TO AUTO. THE PVARP WAS EXTENDED LONGER THAN PREDICTED BECAUSE OF THE AUTO FUNCTION. THE SETTING WAS CHANGED AND THE DEVICE RESPONDED AS EXPECTED. THE ATRIAL AND VENTRICULAR LEADS REMAIN 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 52 YR Required Intervention ADDRL1 IMPLANTABLE PULSE GENERATOR