BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 2953746 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-02027
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 27, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM FOR PASSING OUT AND THAT THERE WAS NO RECORDINGS ON THE DEVICE OR SYMPTOMS RECORDED. A REMOTE MONITORING TRANSMISSION SHOWED THE PATIENT HAD THREE ASYSTOLE EPISODES WHICH ALL SHOWED THE DEVICE WAS UNDERSENSING R-WAVES. THE DEVICE IS STILL 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
    56512 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR