BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESTELLA DR-T

    MDR report key: 6064110 · Received October 28, 2016

    Report

    Report Number
    1028232-2016-04147
    Event Type
    Death
    Date Received
    October 28, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 11, 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.

    Description of Event or Problem · 1

    THE PATIENT EXPIRED ON (B)(6) 2016 DUE TO ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714096 ESTELLA DR-T PACEMAKER NVZ BIOTRONIK SE & CO. KG 371207

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death