BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICS 3000

    MDR report key: 642610 · Received October 20, 2005

    Report

    Report Number
    1028232-2005-00151
    Event Type
    Other
    Date Received
    October 20, 2005
    Date of Event
    October 11, 2005
    Report Date
    October 17, 2005
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    KRG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIS ICS 3000 SHOWED NO MARKER ANNOTATION OR CHARGE BAR DURING DFT TESTING. IN ADDITION, COMPANY AGENT REPORTED THAT THE IEGM WAS NEVER PROPERLY DISPLAYED DURING THE CASE. HE HEARD A LARGE AMOUNT OF BASELINE NOISE. HE WAS NOT ABLE TO DETERMINE CHARGING BASED ON WHEN THE IEGM IS NOT DISPLAYED. THE LUMOS VR BEING IMPLANTED WORKED FINE, AND RESCUED THE PT ON THE THIRD SHOCK. THE NEXT DFT INDUCTION WAS DONE USING AN EPR 1000 AND THE PGH FROM THE 3000. EVERYTHING WORKED NORMALLY ON THE 1000 PROGRAMMER.

    Description of Event or Problem · 1

    THIS ICS 3000 SHOWED NO MARKER ANNOTATION OR CHARGE BAR DURING DFT TESTING. IN ADDITION, MALE REPORTED THAT THE IEGM WAS NEVER PROPERLY DISPLAYED DURING THE CASE. HE SAW A LARGE AMOUNT OF BASELINE NOISE. HE WAS NOT ABLE TO DETERMINE CHARGING BASED ON WHEN THE IEGM IS NOT DISPLAYED. THE LUMOS VR BEING IMPLANTED WORKED FINE, AND RESCUED THE PATIENT ON THE THIRD SHOCK. THE NEXT DFT INDUCTION WAS DONE USING AN EPR 1000 AND THE PGH FROM THE 3000. EVERYTHING WORKED NORMALLY ON THE 1000 PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICS 3000 PROGRAMMER KRG BIOTRONIK GMBH AND CO. 349527 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other