BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 2790996 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02276
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 12, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. THE 2090 MODEL LINE ITEM REPRESENTS THREE DIFFERENT PROGRAMMERS, THE SERIAL NUMBERS ARE UNKNOWN. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    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. THE 2090 MODEL LINE ITEM REPRESENTS THREE DIFFERENT PROGRAMMERS, THE SERIAL NUMBERS ARE UNKNOWN. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE ANALYSIS FOUND NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE MIDDLE OF AN INTERROGATION, THE PROGRAMMER PEN SUDDENLY STOPPED WORKING AND THE PROGRAMMER WAS SHUT DOWN WITHOUT ENDING THE DEVICE CHECK PROPERLY. ONE HOUR LATER THE PHYSICIAN TRIED TO INTERROGATE THE MONITOR AGAIN WITHOUT SUCCESS, EVEN WITH TWO DIFFERENT PROGRAMMERS. THE NEXT DAY THE MONITOR WAS ABLE TO BE INTERROGATED WITH NO PROBLEMS AND ALL THE HISTORY WAS AVAILABLE. THE MONITOR AND PROGRAMMERS REMAIN 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
    1 REVEAL XT IMPLANTABLE LOOP RECORDER DSI MEDTRONIC S.A. 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other