BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 1863210 · Received October 9, 2010

    Report

    Report Number
    6000144-2010-05107
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION, A REVEAL IMPLANTED LOOP RECORDER SHOWED NO VISIBLE R-WAVES ON THE ECG BUT DID SHOW VENTRICULAR SENSE MARKERS. THE SYSTEM REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVEAL DX IMPLANTABLE LOOP RECORDER DSI MEDTRONIC MED REL, INC. 9528 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other