BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTOVIS DR PROMRI

    MDR report key: 3160141 · Received June 10, 2013

    Report

    Report Number
    1028232-2013-01631
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    March 7, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUS MDR - AT THE DISCHARGE FOLLOW-UP THERE WAS AN ALARM REGARDING A LEAD ISSUE ON THE RV-CHANNEL. ALSO WITH UNIPOLAR CONFIGURATION THE IMPEDANCE MEASUREMENT WAS >2500 OHM. FURTHERMORE, RV-SENSING AND RV-PACING WERE NOT POSSIBLE. THE X-RAY OF THE THORAX SHOWED NO LEAD DISLODGEMENT. MOVING THE DEVICE AROUND THE HEADER (IN CASE OF BAD CONNECTION) DIDN'T SHOW ANY ARTIFACTS OR BETTER MEASUREMENTS. ON THE SAME DAY A NEW PACEMAKER WAS CONNECTED AND ALL MEASUREMENTS WERE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260689 ENTOVIS DR PROMRI PACEMAKER DXY BIOTRONIK SE & CO. KG 371991

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization