BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 2812746 · Received October 31, 2012

    Report

    Report Number
    2647346-2012-01794
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 IMPLANTABLE DIAGNOSTIC MONITOR SHOWED BOTH OVERSENSING AND UNDERSENSING ON THE DEVICE RECORDINGS. THE MONITOR REMAINS IN USE. NO 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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other