BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991572 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02130
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 THAT THE VENTRICULAR LEAD SHOWED VARIABLE THRESHOLD AS IT WAS LOW DURING IMPLANT, BUT LATER INCREASED SIGNIFICANTLY AND RETURNED TO "EXPECTED LEVELS SHORTLY AFTER." THE PHYSICIAN FELT THE J-SHAPED STYLETS WERE NOT PROVIDED AS MUCH SUPPORT AS THEY HAD IN THE PAST AND WONDERED IF THERE HAD BEEN ANY CHANGES TO THE CURVE. THE 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
    470599 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1