BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 2965193 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02240
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE LOOP RECORDER (ILR) SHOWED MULTIPLE ASYSTOLE EPISODES THAT THE CLINICIAN SUSPECTED WERE FALSE ASYSTOLE. A REVIEW OF A REMOTE TRANSMISSION FOUND THAT THE ILR WAS BOTH OVERSENSING AND UNDERSENSING. IT WAS NOTED THAT THE IMPLANT SITE WAS UNDER THE CLAVICLE BY THE 1ST RIB. PROGRAMMING CHANGES AND THE POSSIBILITY OF MOVING THE ILR TO A MORE TRADITIONAL IMPLANT SITE WERE DISCUSSED. 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
    67152 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention