BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELLENCE PS+

    MDR report key: 3991512 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08070
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    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 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 DEVICE WAS REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). THE BATTERY LONGEVITY WAS LESS THAN EXPECTED. A NEW DEVICE WAS IMPLANTED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS REPLACED DUE TO SENSING ISSUES. A NEW RV LEAD WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469529 EXCELLENCE PS+ ELECTRODE, PACEMAKER, PERMANENT DTB MPRI IMK49B58

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R JD340U IPG