BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3051291 · Received April 10, 2013

    Report

    Report Number
    2182208-2013-01048
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    July 23, 2012
    Report Date
    July 23, 2012
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; THE PROGRAMMER DISPLAYED AN ERROR MESSAGE AT START-UP. ANALYSIS ALSO FOUND THE STYLUS WAS MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN ERROR MESSAGE AT START-UP. 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
    152274 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090

    Patients

    Seq Age Sex Outcome Treatment
    1