BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 1922351 · Received December 13, 2010

    Report

    Report Number
    6000094-2010-02200
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 17, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. EVALUATION SUMMARY; (B)(4) THE DEVICE WAS RETURNED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE R-WAVE AMPLITUDES WERE LOWER WITH THE IMPLANTED DEVICE THAN WITH THE TEST DEVICE DESPITE BEING POSITIONED IN THE SAME LOCATION. THE PHYSICIAN CHANGED THE POSITION OF THE ELECTRODES AND APPLIED PRESSURE WITH THE PROGRAMMER HEAD, BUT HE WAS NOT ABLE TO FIND A POSITION WITH R-WAVES THAT WERE HIGH ENOUGH. THE DEVICE WAS NOT IMPLANTED. 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 40 YR Other