BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1084936 · Received June 12, 2008

    Report

    Report Number
    3003768277-2008-00009
    Event Type
    Other
    Date Received
    June 12, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    PMA / PMN Number
    K001796
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: IT IS A KNOWN ISSUE THAT PTS WITH A PACEMAKER SHOULD NOT BE SCANNED. THE INSTRUCTIONS FOR USE, SECTION 1.4, "CONTRAINDICATIONS" IN PART STATES: THE PHILIPS INTERA SHOULD NOT BE USED IF ANY OF THE FOLLOWING CONTRAINDICATIONS EXIST OR ARE THOUGHT TO EXIST. THIS DEVICE IS CONTRAINDICATED FOR PTS FITTED WITH METALLIC IMPLANTS OR ELECTRICALLY, MAGNETICALLY, OR MECHANICALLY ACTIVATED IMPLANTS (SUCH AS CARDIAC PACEMAKERS) BECAUSE THE MAGNETIC AND ELECTROMAGNETIC FIELDS PRODUCED BY THE MR DEVICE MAY EXERT STRONG FORCES ON THE METALLIC IMPLANTS OR MAY INTERFERE WITH THE OPERATION OF THESE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * LNH PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1