BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 2053265 · Received April 13, 2011

    Report

    Report Number
    6000144-2011-01612
    Event Type
    Injury
    Date Received
    April 13, 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
    MN, US
    Reporter Occupation
    OTHER

    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 CALLER WAS NOT ABLE TO SEE OLDER EPISODES WHICH APPEAR IN COUNTERS. THE IMPLANTABLE CARDIAC MONITOR DEVICE WAS REMOVED AND NOT REPLACED. THE PACE MAKER WAS IMPLANTED. 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 69 YR Hospitalization| R