BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152440 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00672
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, BUT THE DISPLAY WAS FOUND TO BE OUT OF SPECIFICATION WITH LINES RUNNING THROUGH THE DISPLAY. IT WAS ALSO NOTED THAT THE RING COVER WAS BROKEN AND THE KEYBOARD PAD WAS COSMETICALLY DAMAGED.

    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENTLY THE MENU SCREEN (BOTTOM) WILL ONLY BRING UP A ROLLING BLACK HORIZONTAL LINE WHEN THE MENU BUTTON IS PRESSED. BENCH TESTING WAS ABLE TO DUPLICATE THIS SEVERAL TIMES. IT IS NOTED THE TOP SCREEN WAS NORMAL EVERY TIME. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253033 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1