BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 2964368 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02071
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE HAD MAXED OUT THE NUMBER OF LIFETIME ASYSTOLE EVENTS AND THAT THE DEVICE DATA WAS CLEARED, AND THEN WHEN INTERROGATED AGAIN APPROXIMATELY 12 MONTHS LATER THAT NO ADDITIONAL EPISODES HAD BEEN COLLECTED AND THE PREVIOUS EPISODES WERE NOT ABLE TO BE REVIEWED. IT WAS THOUGHT ODD THAT NO ADDITIONAL EPISODES HAD BEEN COLLECTED. ALSO, IN CLINIC IT WAS POSSIBLE TO DUPLICATE NOISE BUT NO EPISODES WERE COLLECTED. 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
    68816 REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9528

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR