BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 1792293 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03200
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    April 21, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECORDER WAS NOT SENSING. THE DATA REVIEWED SHOWED PAUSES ON THE DAY OF RECORDER IMPLANT AND THERE HAVE BEEN NO PAUSES SINCE. THERE WAS DEVIATION FROM THE BASE LINE AND IT RETURNED QUICKLY TO THE PREVIOUS RATE. THE RECORDER REMAINS 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 DX IMPLANTABLE LOOP RECORDER DSI MEDTRONIC MED REL, INC. 9528 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other