BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 2964870 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02336
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 IMPLANTABLE CARDIAC MONITOR RECORDED EVENTS WITH A SINUS RHYTHM THEN A PAUSE LASTING ABOUT 1 MINUTE, THEN BACK TO A SINUS RHYTHM. THE DEVICE 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
    69259 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR