BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2953314 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00319
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 29, 2012
    Report Date
    December 29, 2012
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    DXY
    PMA / PMN Number
    P890003
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE KEYBOARD WAS MISSING, CAUSING THE LONG BOOT SEQUENCE. WHEN THE KEYBOARD WAS REPLACED THE BOOT SEQUENCE WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER'S BOOT-UP TIME EXCEEDED 90 SECONDS AND THAT IT KEPT REBOOTING. 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
    56419 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090

    Patients

    Seq Age Sex Outcome Treatment
    1