BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 2791577 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05440
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 2, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 IMPLANTABLE CARDIAC MONITOR (ICM) UPON DEVICE INTERROGATION SHOWED AN EPISODE WHERE OVERSENSING IS SUSPECTED. IT WAS ALSO REPORTED THAT NO INTERVENTION WAS PERFORMED. THE ICM 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
    1 REVEAL DX IMPLANTABLE LOOP RECORDER DSI MEDTRONIC MED REL, INC. 9528

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Other