BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 2201623 · Received August 11, 2011

    Report

    Report Number
    6000144-2011-03785
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 16, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 IMPLANTABLE LOOP RECORDER (ILR) MISSED A SUPRAVENTRICULAR TACHYCARDIA (SVT) EPISODE THAT WAS CAUGHT ON A HOLTER, BUT NOT RECORDED BY THE ILR. THERE WAS A QUESTION REGARDING PROGRAMMING AS NOT TO MISS AN SVT AND NOT OVERSENSE SINUS TACHYCARDIA. THE ILR WAS REPROGRAMMED TO CAPTURE ATRIAL FRIBILLATION (AF) AND ATRIAL TACHYCARDIA (AT). IT WAS ALSO NOTED THAT THE PATIENT HAS NOT BEEN ABLE TO USE THE ACTIVATOR AT ALL AND IS DISSATISFIED WITH THE ENTIRE EXPERIENCE. THE ILR 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 XT IMPLANTABLE LOOP RECORDER DSI MEDTRONIC MED REL, INC. 9529 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other