BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2955593 · Received February 11, 2013

    Report

    Report Number
    2182208-2013-00369
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    RICE CREEK MFG
    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

    (B)(4). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHILE ATTEMPTING TO INTERROGATE THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG), THE STYLUS PEN LOCKED UP. THE PHYSICIAN SHUT THE PROGRAMMER DOWN. WHEN A NEW PROGRAMMER WAS BROUGHT IN AND THE DEVICE INTERROGATED, THE INFORMATION ON THE IPG WAS NOT AVAILABLE. IT WAS FOUND THAT THE IPG WAS IN A CLEARING MODE AND WAS UNABLE TO PROVIDE THE DATA; THUS WORKING AS EXPECTED. THE STATUS OF THE PROGRAMMER AND STYLUS PEN IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57971 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR