BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2954752 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01516
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    July 13, 2006
    Report Date
    December 13, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    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 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER IMPLANT THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO BE DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. 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
    59499 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R