BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 2811434 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06082
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 15, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 CARDIAC MONITOR (ICM) DEVICE FALSELY RECORDED SEVERAL ATRIAL FIBRILLATION (AF) EPISODES. IT WAS ALSO REPORTED THAT THE PATIENT COLLAPSED AND NO NEW EPISODES WERE RECORDED. IT WAS FURTHER REPORTED THAT THE ICM DEVICE SETTING FOR AF DETECTION WAS REPROGRAMMED TO A LESS SENSITIVE VALUE TO PREVENT FURTHER INAPPROPRIATE STORAGE OF EPISODES. THE ICM DEVICE 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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention