BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 8623200 · Received May 20, 2019

    Report

    Report Number
    9614453-2019-01620
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 26, 2019
    Report Date
    May 20, 2019
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    DSI
    UDI-DI
    00643169845749
    PMA / PMN Number
    K132649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    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) EXPERIENCED R-WAVE UNDERSENSING. 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
    416667 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC EUROPE SARL LNQ11 00643169845749

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR