BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2952127 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00124
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 29, 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 FOUND THAT THE DEVICE POWERED UP TO AN ERROR. IT WAS ALSO NOTED THAT THE POWER CORD BAY WAS BROKEN, AND THE HINGE PLATE SCREWS WERE MISSING. PRODUCT ID 2067 RADIOFREQUENCY HEAD; PRODUCT ID 229047 ANALYZER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT BOOT UP COMPLETELY, THAT IT WAS POWERING ON TO A BLANK SCREEN. THE PROGRAMMER WAS RETURNED FOR REPAIR. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56709 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090

    Patients

    Seq Age Sex Outcome Treatment
    1