BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL DX

    MDR report key: 1861503 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04815
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. RAB445399H THE DEVICE WAS RETURNED, ANALYCED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STRIP SHOWED A VERY LONG EPISODE OF ASYSTOLE. A VERY FLAT BASELINE WITHOUT A GENERAL WAVE TO IT WAS ALSO SHOWN. AT THE END OF THE ASYSTOLE THERE APPEARED TO BE AN UP TICK. IT WAS QUESTIONED IF THE EPISODE WAS REAL. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STRIP SHOWED A VERY LONG EPISODE OF ASYSTOLE. A VERY FLAT BASELINE WITHOUT A GENERAL WAVE TO IT WAS ALSO SHOWN. AT THE END OF THE ASYSTOLE THERE APPEARED TO BE AN UP TICK. IT WAS QUESTIONED IF THE EPISODE WAS REAL. IT WAS LATER REPORTED THE DEVICE WAS REMOVED. FOLLOW UP DISCLOSED THE PATIENT REQUESTED THE DEVICE BE REMOVED. NO SYNCOPAL EPISODES OR RECORDINGS WERE NOTED ON THE DEVICE STRIP. 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 MED REL, INC. 9528 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O| R