BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3860040 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05629
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 DURING IMPLANT ATTEMPT, THE PATIENT EXPERIENCED SEVERE TRICUSPID REGURGITATION, AND THE LEAD BECAME DISLODGED. THE PHYSICIAN DECIDED TO REPLACE THE LEAD WITH AN ACTIVE FIXATION MODEL, WHICH WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340243 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5092-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR