BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964591 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02147
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    September 12, 2012
    Report Date
    December 27, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 THE PATIENT SUFFERED A PNEUMOTHORAX FROM THE VEIN PUNCTURE DURING IMIPLANT. A THORAXDRAIN WAS PLACED. THE LEADS REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE MARC CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED ASA RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67113 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| L| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC