BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TBD

    MDR report key: 3050975 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04772
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    May 11, 2008
    Report Date
    January 8, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 THERE WAS A LOSS OF CAPTURE NOTED WITHIN APPROXIMATELY ONE MONTH AFTER THE IMPLANT OF THE RIGHT ATRIAL LEAD AND A LEAD DISLODGMENT WAS SUSPECTED. THE LEAD WAS INACTIVATED THROUGH PROGRAMMING. THE PATIENT WAS REPORTED TO HAVE BEEN ENROLLED IN THE MINERVA POST MARKET CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151851 TBD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5592-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention