BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC REVEAL XT MONITOR

    MDR report key: 6016669 · Received October 6, 2016

    Report

    Report Number
    MW5065260
    Event Type
    Other
    Date Received
    October 6, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 6, 2016
    Manufacturer
    MEDTRONIC
    Product Code
    DSI
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OUTPATIENT SCANNED IN ERROR ON MRI 1.2T. LOW FIELD MAGNET INSTEAD OF RECOMMENDED 1.5T. NO ADVERSE EFFECTS OR COMPLICATIONS NOTED. F/U WITH PT REVEALED NO COMPLAINTS. PT'S DOCTOR'S OFFICE ALSO NOTIFIED. PT INSTRUCTED TO DO MANUAL UPLOAD ON DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661470 MEDTRONIC REVEAL XT MONITOR REVEAL XT DSI MEDTRONIC 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR