BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 1864918 · Received October 12, 2010

    Report

    Report Number
    6000144-2010-05228
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    July 29, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT AWOKE IN THE MIDDLE OF THE NIGHT WITH SHARP CHEST PAIN RADIATING UP TO JAW AND OVER TO LEFT ARM RADIATING FROM DEVICE. PAIN IN THE NECK WAS ALSO REPORTED. THE PATIENT WENT TO THE EMERGENCY ROOM. AN EPISODE WAS STORED ON THE RECORDER AT AROUND THE SAME TIME THAT SHOWS NORMAL SINUS RHYTHM WITH NOISE. THE DEVICE 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
    1 REVEAL XT IMPLANTABLE LOOP RECORDER DSI MEDTRONIC MED REL, INC. 9529 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other