BEUDAMED
    FDA Adverse Event Other Summary report: N

    INOS 2 DR

    MDR report key: 535202 · Received March 18, 2004

    Report

    Report Number
    1028232-2003-00334
    Event Type
    Other
    Date Received
    March 18, 2004
    Report Date
    December 5, 2003
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    OUS MDR DURING VENTRICULAR THRESHOLD TEST PROGRAMMER STOPPED WORKING. WHEN TESTED THE FOLLOWING WEEK WITH A DIFFERENCE PROGRAMMER, THE PACEMAKER HAS RESET TO VVI.

    Description of Event or Problem · 1

    OUS MDR DURING VENTRICULAR THRESHOLD TEST PROGRAMMER STOPPED WORKING. WHEN TESTED THE FOLLOWING WEEK WITH A DIFFERENCE PROGRAMMER, THE PACEMAKER HAS RESET TO VVI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOS 2 DR PACEMAKER DXY BIOTRONIK GMBH & CO. 122 130 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization