BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 1991797 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00290
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO TRANSMIT ANY DATA FROM THIS INSERTABLE CARDIAC MONITOR (ICM) SINCE (B)(6) 2010. DURING INTERROGATION THERE WAS NO ON-SCREEN LIVE ELECTROCARDIOGRAM FROM THE ICM. ACCORDNG TO THE REPORTER, THE DEVICE REMAINS IN USE AS DIAGNOSTIC EVALUATION IS STILL BEING PERFORMED BY THE DEVICE ALTHOUGH THEY ARE NOT SURE IF IT IS ACTUALLY WORKING CORRECTLY. 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 DX IMPLANTABLE LOOP RECORDER DSI MEDTRONIC S.A. 9528 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other