BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELLENCE PS+

    MDR report key: 4161026 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11684
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR 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 DURING AN IMPLANT PROCEDURE, AFTER THE LEAD WAS IMPLANTED, THE THRESHOLD WAS TOO HIGH. THIS LEAD WAS REMOVED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642523 EXCELLENCE PS+ ELECTRODE, PACEMAKER, PERMANENT DTB MPRI IMK49B58

    Patients

    Seq Age Sex Outcome Treatment
    1