BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 2813337 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06386
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 24, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. EVALUATION SUMMARY: (B)(4) - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. REPORT - INTERFERENCE/NOISE: PROGRAMMER S2D FILE (B)(4), SHOWS VARIOUS NOISE IN EGM DATA IN 10 - FVT EPISODES ON (B)(4) 2012 IN THE TIMEFRAME BETWEEN 11:29:30 AND 12:25:38.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RECORDED AN EPISODE THAT WAS DETERMINED TO BE NOISE. THE 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 55 YR Other