BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDORA 8 DR-T

    MDR report key: 6993278 · Received November 1, 2017

    Report

    Report Number
    6993278
    Event Type
    Injury
    Date Received
    November 1, 2017
    Date of Event
    September 14, 2017
    Report Date
    October 27, 2017
    Manufacturer
    BIOTRONIK INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A BIOTRONIK PACEMAKER THAT WAS IMPLANTED AND WAS SEEN BACK FOR WOUND CHECK IN 1 WEEK WITH NORMAL FUNCTION BUT ALSO SEEN SIX WEEKS LATER DUE TO PATIENT SYMPTOMS AND WAS NOT ABLE TO BE INTERROGATED WITH NUMEROUS ATTEMPTS AND TECH SERVICE INVOLVEMENT. IT ALSO STOPPED COMMUNICATING WITH THE HOME-MONITOR ABOUT A WEEK AGO. LIKELY RANDOM COMPONENT FAILURE BUT HARD TO SAY THIS DEVICE WAS JUST RELEASED ABOUT 6 MONTHS AGO. BIOTRONIK EDORA 8 DR-T PRO MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772901 EDORA 8 DR-T PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ BIOTRONIK INC. 407145

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R