BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2952701 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00219
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPOTED EVENT, THE PROGRAMMER HAD A BLANK SCREEN FOR OVER 20 MINUTES AND THEN AN ERROR WAS DISPLAYED. SOFTWARE WAS RELOADED. IT WAS ALSO NOTED THAT THE POWER CORD DOOR WAS MISSING, AND THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE ON THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD A BLANK SCREEN AND WOULD NOT START. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57155 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1