BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTOVIS DR-T PROMRI COATED

    MDR report key: 3053643 · Received April 11, 2013

    Report

    Report Number
    1028232-2013-00945
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 28, 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

    Additional Manufacturer Narrative · 1

    AFTER ITS RETURN, THE PACEMAKER FIRST UNDERWENT AN ELECTRICAL INCOMING GOODS INSPECTION. AN INITIAL INTERROGATION WAS NOT POSSIBLE, AND THE IMPLANT WAS NOT ABLE TO PROVIDE THERAPY. THEREFORE, THE PACEMAKER WAS OPENED AND THE COMPONENTS OF THE ELECTRONIC MODULE WERE INSPECTED. THE BATTERY WAS DISCHARGED. FURTHERMORE, A DAMAGED CAPACITOR WAS IDENTIFIED, WHICH CAUSED AN INCREASED POWER CONSUMPTION AND CONSEQUENTLY LED TO THE CLINICAL OBSERVATION. THE COMPONENT WAS REMOVED FROM THE ELECTRONIC MODULE, AND THE CURRENT UPTAKE THEN PROVED TO BE AS EXPECTED. THERE WEREN'T ANY OTHER CAUSES FOR THE INCREASED CURRENT UPTAKE THAN THE DAMAGED CAPACITOR. IN ADDITION, THE MANUFACTURING PROCESS FOR THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS DID NOT SHOW ANY ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS HAD BEEN CARRIED OUT CORRECTLY, AND THE POWER CONSUMPTION OF THE PACEMAKER IN PARTICULAR WAS UNREMARKABLE. IN SUMMARY, THE CLINICAL OBSERVATION RESULTED FROM AN INCREASED CURRENT UPTAKE, WHICH WAS CAUSED BY A DAMAGED CAPACITOR OF THE ELECTRONIC MODULE. THE CHECK OF THE PRODUCTION HISTORY SHOWED THAT THE DEVICE FUNCTIONED PROPERLY AT THE TIME OF ITS SHIPMENT.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 20 MONTHS, A LOSS OF CAPTURE WAS REPORTED. THE PATIENT REPORTED FEELING CONSTANTLY TIRED. THE PACEMAKER WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156034 ENTOVIS DR-T PROMRI COATED PACEMAKER DXY BIOTRONIK SE & CO. KG 372028

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization