BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4833502 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07067
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT, THE GUIDEWIRE WAS UNABLE TO ENTER AND REACH THE END OF THE LEADS, THEREFORE THE PHYSICIAN WAS UNABLE TO BEND THE END OF THE LEADS TO THE DESIRED DEGREE. IN ADDITION, THE PHYSICIAN EXPRESSED DIFFICULTY OPERATING THE LEADS. THE LEADS WERE EVENTUALLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380465 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR