BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL DX

    MDR report key: 1873730 · Received September 30, 2010

    Report

    Report Number
    6000144-2010-04279
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    January 15, 2010
    Report Date
    January 15, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) FOR A 2 YEAR RETROSPECTIVE REVIEW OF REPORTED EVENTS WHERE THE PRODUCT WAS STILL IN USE; DATA RANGE 03/30/2008 AND 03/29/2010. THIS MEDWATCH REPORT REPRESENTS 1 OF 262 EVENTS (EVENT TYPE CODE MALFUNCTION. 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 THERE WAS AN ERROR RECEIVED WHEN TRYING TO PRINT EPISODE DATA. NO PATIENT COMPLICATIONS HAVE RESULTED FROM THIS EVENT. THE DEVICE REMAINS ACTIVATED AND IN USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other