BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2952676 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00206
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    DXY
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE PROGRAMMER DID NOT RESPOND TO THE STYLUS PEN. THE OVERLAY/BEZEL ASSEMBLY WAS REPLACED AND THE STYLUS WAS CALIBRATED. PRODUCT ID 229047 ANALYZER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DID NOT RESPOND TO THE TOUCH STYLUS PEN. CHANGING OUT THE PEN FOR ONE THAT WAS KNOWN TO WORK DID NOT RESOLVE THE SITUATION. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56235 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090

    Patients

    Seq Age Sex Outcome Treatment
    1