BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIA DR-T

    MDR report key: 3894265 · Received June 25, 2014

    Report

    Report Number
    1028232-2014-002166
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    THIS PACEMAKER WAS EXPLANTED AND REPLACED BECAUSE THE PHYSICIAN THOUGHT THAT IT HAD SENSING ISSUES. THE RV LEAD WAS EXPLANTED AND REPLACED AS WELL DUE TO MICRO-DISLODGEMENT. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370028 EVIA DR-T PACEMAKER DXY BIOTRONIK SE & CO. KG 359529

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization