BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACTROS DR+

    MDR report key: 542077 · Received August 26, 2004

    Report

    Report Number
    1028232-2004-00098
    Event Type
    Other
    Date Received
    August 26, 2004
    Date of Event
    July 21, 2004
    Report Date
    August 19, 2004
    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

    RATE RESPONSE INAPPROPRIATE; DEVICE RAMPED UP TO MAX SENSOR RATE WHILE PT 'STILL', DESPITE PROGRAMMING. WHENEVER WAND WAS REMOVED, THIS WOULD HAPPEN.

    Description of Event or Problem · 1

    RATE RESPONSE INAPPROPRIATE; DEVICE RAMPED UP TO MAX SENSOR RATE WHILE PT 'STILL', DESPITE PROGRAMMING. WHENEVER WAND WAS REMOVED, THIS WOULD HAPPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTROS DR+ PACEMAKER DXY BIOTRONIK GMBH & CO. 122 311 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization