BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL XT

    MDR report key: 1991281 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00861
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    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. LIFETIME ASYSTOLE EPISODE COUNTER: 4051.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED BOTH UNDERSENSING AND T-WAVE OVERSENSING. THE PATIENT HAS HAD MANY ASYSTOLE EVENTS THAT ARE APPARENTLY UNDERSENSED R WAVES. THE DEVICE IS STILL 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other