BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2952172 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00130
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    RICE CREEK MANUFACTURING
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE LONG BOOT TIME AND THEN BOOTS TO AN ERROR. SOFTWARE WAS RELOADED TO ADDRESS THIS ISSUE. IT WAS ALSO NOTED THAT THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE ON THE CIRCUIT BOARD, THE SYSTEM FAN WAS NOISY, THE TAB ON THE POWER CORD BAY DOOR WAS BENT, AND THE HANDLES WERE BROKEN. PRODUCT ID 2067 RADIOFREQUENCY HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER BOOTED UP TO A BLACK SCREEN WITH A "SERIOUS PROGRAMMER ERROR." THE SERVICE DISKETTE WAS RUN BUT THE SITUATION DID NOT RESOLVE. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55912 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1