BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 3614603 · Received February 8, 2014

    Report

    Report Number
    3004209178-2014-01936
    Event Type
    Malfunction
    Date Received
    February 8, 2014
    Date of Event
    December 2, 2013
    Report Date
    December 2, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT PRODUCTS: ILXC1414135 STENT GRAFT, (B)(6) 2006-06-05; YRBRHXC2414165 STENT GRAFT, (B)(6) 2006-. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED DURING AN EPISODE ON THE PATIENT'S IMPLANTABLE CARDIAC MONITOR. THE CARDIAC 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
    82285 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR