BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152960 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01374
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    November 20, 2007
    Report Date
    March 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
    EZ
    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. CONTINUATION: ADD01 IMPLANTABLE PULSE GENERATOR 2007-(B)(6), 5076 IMPLANTABLE PACING LEAD 2007-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A WEEK POST IMPLANT THE RIGHT ATRIAL (RA) LEAD DISLODGED. THE RA LEAD WAS REPOSITIONED AND REMAINS IN USE. IT WAS NOTED THAT THE PATIENT IS PART OF THE (B)(6) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256120 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R