BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELUNA 8 DR-T PROMRI

    MDR report key: 6067952 · Received October 31, 2016

    Report

    Report Number
    1028232-2016-04219
    Event Type
    Death
    Date Received
    October 31, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 17, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND ANALYZED. THE MEMORY CONTENT OF THE PACEMAKER WAS INSPECTED, SHOWING A NORMAL DEVICE FUNCTION WHILE IMPLANTED AND IN SERVICE. THE PACEMAKER WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE NORMAL AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. IN CONCLUSION, THE DEVICE PROVED TO BE FULLY FUNCTIONAL. THE ANALYSIS OF THE MEMORY CONTENT SHOWED A NORMAL DEVICE BEHAVIOR WHILE THE DEVICE WAS IMPLANTED AND IN SERVICE. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS VERY SICK BUT THE PHYSICIAN CHOSE TO IMPLANT A PACEMAKER SYSTEM. THIS SYSTEM WAS ATTEMPTED BUT NOT IMPLANTED BECAUSE WHILE TESTING THE LEADS DURING IMPLANT THERE WAS NO SENSING AND THE PATIENT CODED. THE ENTIRE SYSTEM WAS REMOVED AND THE PATIENT BECAME STABLE AGAIN AFTER BEING WORKED ON BY THE PHYSICIAN. LATER THAT EVENING THE PATIENT EXPIRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718930 ELUNA 8 DR-T PROMRI PACEMAKER NVZ BIOTRONIK SE & CO. KG 394969

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death