BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTOS DR

    MDR report key: 567884 · Received January 12, 2005

    Report

    Report Number
    1028232-2004-00159
    Event Type
    Other
    Date Received
    January 12, 2005
    Date of Event
    December 20, 2004
    Report Date
    January 3, 2005
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    OOS REPORT STATES 'REED SWITCH STUCK-COULD NOT INTERROGATE OR GET TEN @ 90.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTOS DR PACEMAKER DXY BIOTRONIK, INC. 122 300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization