BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2952677 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00205
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    DXY
    PMA / PMN Number
    P890003/S145
    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 REPORTED EVENT, THE SCREEN OF THE PROGRAMMER WAS CRACKED AND NOT RESPONDING TO THE STYLUS PEN. THE OVERLAY BEZEL ASSEMBLY WAS REPLACED AND THE STYLUS WAS CALIBRATED. PRODUCT ID 2067L RADIOFREQUENCY HEAD; PRODUCT ID (B)(4)7 ANALYZER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN OF THE PROGRAMMER WAS CRACKED AND WAS NO LONGER RESPONDING TO THE STYLUS TOUCH PEN. 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
    57102 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090

    Patients

    Seq Age Sex Outcome Treatment
    1