BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2864803 · Received December 10, 2012

    Report

    Report Number
    2183613-2012-02045
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    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. EVALUATION SUMMARY: ANALYSIS CONFIRMED THE DISPLAY PROBLEM, THE PRINTED CIRCUIT BOARD WAS RESEATED. ANALYSIS WAS UNABLE TO CONFIRM THE REPORT RELATED TO THE ANALYZER, THE ANALYZER WAS NOT RETURNED WITH THE PROGRAMMER.

    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).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN ON THE PROGRAMMER WAS NOT WORKING PROPERLY. IT WAS ALSO REQUESTED THAT THE ANALYZER CONNECTOR BE CHECKED AS AN OCCASIONAL MESSAGE WOULD APPEAR THAT THE ANALYZER WAS NOT CONNECTED. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN ON THE PROGRAMMER WAS NOT WORKING PROPERLY. IT WAS ALSO REQUESTED THAT THE ANALYZER CONNECTOR BE CHECKED AS AN OCCASIONAL MESSAGE WOULD APPEAR THAT THE ANALYZER WAS NOT CONNECTED. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC MILACA, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1