BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 1922162 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05875
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    August 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    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 PATIENT MAY BE EXPERIENCING ASYSTOLE. AFTER REVIEWING THE EPISODE IT WAS DETERMINED TO BE DROP OUT OF SIGNAL, NOT TRUE ASYSTOLE. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF 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 51 YR Other