BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 2813091 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06572
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    May 8, 2012
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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

    PRODUCT EVENT SUMMARY #THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. NO KNOWN ISSUES WERE NOTED ON THE DATA, BUT IT WAS SUSPECTED THAT EXPOSURE TO CONTINUOUS NOISE SOURCE CAUSED MARKERS TO BE MISSING FROM THE ELECTROGRAM.

    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 MARKERS STOPPED DURING THE EPISODE RECORDED BY THE IMPLANTABLE CARDIAC MONITOR (ICM). IT WAS ALSO REPORTED THAT THE ICM HAD NOISE AS FOUND IN THE PERFORMANCE DATA OF THE DEVICE. 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
    1 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other