BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTELLA DR-T PROMRI

    MDR report key: 3021792 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00491
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 14, 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

    OUS MDR.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS AND THE RETURNED DATA. THE MANUFACTURING PROCESS OF THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS DID NOT SHOW ANY ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS WERE CARRIED OUT CORRECTLY. THE RETURNED DATA WERE ANALYZED IN DETAIL. THE ANALYSIS OF THE DATA DID NOT SHOW ANY INDICATIONS OF A PACEMAKER MALFUNCTION. RATHER, THE CLINICAL OBSERVATION RESULTED FROM THE CHOSEN PARAMETER SETTINGS AND A VENTRICULAR EVENT WITHIN THE SAFETY WINDOW. IN RESPONSE, THE AV DELAY WAS SHORTENED IN SUCH A WAY THAT THE PACING RATE TEMPORARILY ROSE TO 200 PPM. IN SUMMARY, THE CLINICAL OBSERVATIONS RESULTED FROM A COMBINATION OF THE CHOSEN PARAMETER SETTINGS AND A VENTRICULAR EVENT WITHIN THE SAFETY WINDOW. THERE WERE NO INDICATIONS OF A DEVICE DYSFUNCTION.

    Description of Event or Problem · 1

    OUS MDR - A HIGH PACING RATE WAS REPORTED. NO IMPLANTATION DATE WAS REPORTED. THE WHEREABOUTS OF THE PRODUCT ARE CURRENTLY NOT KNOWN. NO DETERIORATION OF THE PT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123609 ESTELLA DR-T PROMRI PACEMAKER DXY BIOTRONIK SE & CO. KG 377383

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other