BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIA DR-T

    MDR report key: 2771463 · Received September 28, 2012

    Report

    Report Number
    1028232-2012-02437
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    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
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE COULD NOT BE INTERROGATED DURING A FOLLOW UP. STANDARD INTERROGATION TROUBLESHOOTING WAS PERFORMED WITHOUT SUCCESS. IT WAS RECOMMENDED TO THE PHYSICIAN THAT THE DEVICE BE EXPLANTED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVIA DR-T PACEMAKER NVZ BIOTRONIK SE & CO. KG 359529

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization