BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILOS II DR-T

    MDR report key: 1323517 · Received February 20, 2009

    Report

    Report Number
    MW5010049
    Event Type
    Injury
    Date Received
    February 20, 2009
    Date of Event
    February 20, 2009
    Report Date
    February 20, 2009
    Manufacturer
    BIOTRONIK
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MAGNET APPLICATION OVER BIOTRONIK PHILOS II DR-T CAUSED FAILURE OF CAPTURE FOR APPROX 6 SECONDS WITH TRANSIENT LOSS OF CONSCIOUSNESS. FIRST APPLICATION WAS WITH BIOTRONIK PROGRAMMER HEAD CONTAINING MAGNET CAUSING ABOUT 6 SECONDS OF LOSS OF CAPTURE. 2ND APPLICATION WAS MAGNET APPLICATION ONLY FOR 1 SEC RESULTING IN 6 SECONDS OF DUAL PACER SPIKES WITH NO CAPTURE AND TRANSIENT LOSS OF CONSCIOUSNESS. DEVICE IMPLANTED IN 2006 WITH ATRIAL LEAD SELOX S AND VENTRICULAR LEAD SELOX SR. PATIENT ADMITTED TO HOSPITAL AND WILL HAVE PULSE GENERATOR REMOVED IN 2009. PULSE GENERATOR WILL BE RETURNED TO MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS II DR-T PACEMAKER, DUAL CHAMBER DXY BIOTRONIK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L