BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 4833610 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-11195
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 6, 2015
    Report Date
    March 6, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS, LIGHTHEADEDNESS, PRESYNCOPE AND PALPITATIONS DUE TO NOISE ON THE IMPLANTABLE CARDIAC MONITOR. THE PATIENT IS A PARTICIPANT IN THE REVEAL ATRIAL FIBRILLATION STUDY. THE ICM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374977 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR