BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 2965037 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02271
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    October 9, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) WAS RECORDING FALSE ASYSTOLE EPISODES. IT WAS ALSO REPORTED THAT THERE WERE "NO R WAVES AT ALL". THE (ICM) 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
    67141 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR