BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3051820 · Received April 10, 2013

    Report

    Report Number
    2182208-2013-01067
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    October 27, 2008
    Report Date
    January 11, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 HAD BEEN HOSPITALIZED 9 DAYS DUE TO RIGHT VENTRICULAR (RV) LEAD DISLODGEMENT. THE RV LEAD WAS BEEN REPLACED. THE PATIENT WAS ENROLLED IN THE (B)(4)STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153278 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R