BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS DR

    MDR report key: 1112069 · Received August 5, 2008

    Report

    Report Number
    1028232-2008-00817
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    March 10, 2008
    Report Date
    July 4, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THIS PACEMAKER DID NOT SHOW ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. IT IS COMPLETELY WITHIN ITS SPECIFICATIONS. THE PACEMAKER WAS NOT THE ROOT CAUSE FOR THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    OUS MDR. PER COMPLAINT FROM THE UK. FAILURE TO PACE. PATIENT HAD RHYTHM OF 35 BPM WHEN PACEMAKER SET AT 60 BPM. LOOKED LIKE OVERSENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOS DR PACEMAKER DXY BIOTRONIK GMBH AND CO 338845

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization