BEUDAMED
    FDA Adverse Event Other Summary report: N

    BA03 DDDR

    MDR report key: 643608 · Received October 27, 2005

    Report

    Report Number
    1028232-2005-00154
    Event Type
    Other
    Date Received
    October 27, 2005
    Date of Event
    September 8, 2005
    Report Date
    October 26, 2005
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DEVICE RECEIVED IN 2005. SALES REP CANNOT INTERROGATE DEVICE. SUGGESTED DIFFERENT PROGRAMMER IN DIFFERENT ROOM. SEVEN DAYS LATER, REP USING DIFFERENT PROGRAMMER COULD NOT INTERROGATE DEVICE. PT SEEN FOR FOLLOW-UP 6 OR 7 MONTHS AGO WITH 2.7X BATTERY VOLTAGE. REP SAYS DEVICE WILL BE EXPLANTED NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BA03 DDDR PACEMAKER DXY BIOTRONIK GMBH AND CO. 122126 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention