BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELLENCE+

    MDR report key: 3993646 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09219
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    December 4, 2013
    Report Date
    May 29, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    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 IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). THE HEALTHCARE PROFESSIONAL BELIEVES THAT THE IPG BATTERY RAPIDLY DEPLETED WITHIN A VERY SHORT SPACE OF TIME. IN ADDITION, IT WAS REPORTED THAT RV LEAD HAD REVERTED TO MAX OUTPUT/HIGH THRESHOLDS. SUBSEQUENT TESTING REVEALED THAT THE THRESHOLDS HAD RETURNED TO NORMAL LEVELS. IT WAS ADDITIONALLY REPORTED THAT THE RV LEAD ENCOUNTERED A LEAD WARNING INDICATING HIGH IMPEDANCE AND A LEAD FRACTURE WAS SUSPECTED. NO ACTIONS/INTERVENTION WAS PERFORMED AND THE RV LEAD REMAINS IN USE. IT WAS SUGGESTED THAT IF THE RV LEAD IS STILL IN USE WITH NORMAL THRESHOLDS TO CHECK LEAD PROGRAMMING/SETTINGS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471902 EXCELLENCE+ DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI IMD49B

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR SEDR01 IPG