BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 4161747 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02254
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. PRODUCT EVENT SUMMARY: PRODUCT PERFORMANCE INFORMATION WAS RETURNED AND ANALYZED. INVALID DATA WAS NOTED ON THE RATE HISTOGRAMS. A PRIOR TRANSMISSION WITHIN 90 DAYS OF REPORT HAD INCORRECT TRANSMISSION DATE AFFECTING THE ALGORITHM. THE DATA ISSUE IS CORRECTABLE BY SWITCHING TO A 30 DAY VIEW WHEN INCORRECT TRANSMISSION DATE IS >90 DAYS OLD OR UPDATING MONITOR TO LATEST SOFTWARE VERSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE INVALID HISTOGRAMS ON THE REMOTE MONITORING TRANSMISSION DATA, BUT THE HISTOGRAMS INDICATE THAT NO DATA IS AVAILABLE. 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
    639138 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR