BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 2951694 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01583
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    September 7, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO, JUNCOS
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY OF IMPLANT AND ONE DAY POST IMPLANT, THE DEVICE ASYSTOLE EPISODES BUT THE PATIENT WAS NOT SYMPTOMATIC. THE EPISODES APPEAR TO BE LOSS OF CONTACT. 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
    57172 REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC PUERTO RICO OPERATIONS CO, JUNCOS 9528

    Patients

    Seq Age Sex Outcome Treatment
    1