BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 4832767 · Received June 10, 2015

    Report

    Report Number
    9614453-2015-01548
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 9, 2015
    Report Date
    May 22, 2018
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    DSI
    Removal / Correction Number
    Z-1249-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT CANNOT BE CONFIRMED THAT THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. IT IS INCLUDED IN THE FIELD ACTION IN THE ABUNDANCE OF CAUTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION NOTED BUT RETURNED PRODUCT INVESTIGATION FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. THE DEVICE IS NO LONGER INCLUDED AS PART OF THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS AT END OF SERVICE (EOS) AND THAT THE DEVICE WAS UNDERSENSING R-WAVES. THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CLINICIAN THAT THERE WAS A BRADYCARDIA EPISODE THAT WAS A FALSE POSITIVE THAT THE IMPLANTABLE LOOP RECORDER (ILR) WAS UNDERSENSING. THE PATIENT WILL BE BROUGHT INTO THE OFFICE TO ADJUST SENSITIVITY. THE ILR REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378482 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC EUROPE SARL LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR