BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2865075 · Received December 10, 2012

    Report

    Report Number
    2183613-2012-02055
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 21, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD WAS CALIBRATED AND SOFTWARE WAS RELOADED. IT WAS ALSO NOTED THAT THE SYSTEM FAN WAS NOISY. (B)(4)

    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 THAT THE PROGRAMMER WAS OPENED AND A PROGRAMMER ERROR WAS NOTED. THE SERVICE DISK WAS RUN BUT THE ERROR WAS NOT ABLE TO BE CLEARED. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS OPENED AND A PROGRAMMER ERROR WAS NOTED. THE SERVICE DISK WAS RUN BUT THE ERROR WAS NOT ABLE TO BE CLEARED. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR SERVICE. BOTH PRODUCTS WERE ANALYZED AND TESTED OUT OF SPECIFICATION. IT WAS INDICATED 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