BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 2532863 · Received April 12, 2012

    Report

    Report Number
    6000144-2012-02501
    Event Type
    Malfunction
    Date Received
    April 12, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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 PATIENT HAD A RECORDER IMPLANTED AND IS NOW IS HAVING DISCOMFORT AND PAIN GREATER THAN THE EXPECTED SEVERITY AND DURATION OUTLINED IN EXPECTED EVENTS FOR THE (B)(4) STUDY - MANAGEMENT OF NEW-ONSET POSTOPERATIVE ATRIAL FIBRILLATION UTILIZING IMPLANTABLE LOOP RECORDER TECHNOLOGY TO OBSERVE RECURRENCE OF AF (MONITOR-AF). FOLLOW-UP WAS CONDUCTED AND FROM THE INFORMATION OBTAINED, IT WAS REPORTED THAT THE PAIN HAS IMPROVED AND NO ADDITIONAL MEDICATIONS WERE GIVEN OTHER THAN THE POST BYPASS MEDICATIONS. THE RECORDER REMAINS IN USE. NO FURTHER 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 Other