BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3864997 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07565
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    August 9, 2013
    Report Date
    August 13, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. CONCOMITANT MEDICAL PRODUCTS: D364TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR: (B)(6) 2013. A 3830 LEAD: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A WOUND REVISION WAS PERFORMED DUE TO THE SUPERFICIAL POSITION OF THE LEADS. THE DEVICE WAS REPOSITIONED AND THE DEVICE AND LEADS REMAIN IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) CLINICAL TRIAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341021 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R G0185 LEAD