BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILOS II DR

    MDR report key: 697255 · Received April 6, 2006

    Report

    Report Number
    1028232-2006-00040
    Event Type
    Other
    Date Received
    April 6, 2006
    Date of Event
    March 20, 2006
    Report Date
    March 27, 2006
    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

    PHYSICIAN USED ELECTROCUATERY DIRECTLY OVER DEVICE. AFTERWARDS, ATTEMPTED TO RESET THE DEVICE WHICH WAS IN BACKUP MODE USING ICS 3000. PROGRAMMER CRASHED DURING RESET, USED TMS 1000, BUT WAS UNABLE TO COMMUNICATE WITH THE DEVICE. RETRIEVED ICS 3000 (504.U) FROM CAR, BUT THAT DEVICE WOULD NOT BOOT UP. HAD PHYSICIAN REOPEN PT (STILL IN STERILE FIELD) AND REMOVE THE PACAMAKER AND REPLACE WITH NEW PHILOS II DR. WHICH COMMUNICATED WITH BOTH THE ICS AND TMS PROGRAMMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS II DR PACEMAKER DXY BIOTRONIK GMBH AND CO. 341826 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention