BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951528 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00055
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CALLER THAT THE NURSE STATED THAT WHILE DOING A FOLLOW UP CHECK WITH A PATIENT, THE PROGRAMMER "LOCKED UP" AND DISPLAYED AN ERROR MESSAGE. THE NURSE RECYCLED THE POWER AND THE ERROR CLEARED. BECAUSE THE NURSE WAS CONCERNED ABOUT THE CAUSE OF THE ERROR, THE CASE WAS FINISHED WITH ANOTHER PROGRAMMER. ADDITIONALLY, THE SALES REPRESENTATIVE (SR) POWERED ON THE PROGRAMMER AND THE ERROR HAD CLEARED. THE SR MANUALLY LOADED AN APPLICATION ON THE PROGRAMMER AND IT APPEARED TO BE FUNCTIONING PROPERLY AND NO ERROR OCCURRED. THE SR WILL TRY IT ON ANOTHER PATIENT TO SEE IF THERE ARE ANY FURTHER ISSUES. IF THERE ARE NO ISSUES, THE PROGRAMMER WILL REMAIN IN USE. TECHNICAL SERVICES (TS) INDICATED THAT SINCE THE ERROR CLEARED UPON RECYCLING THE POWER AND THE APPLICATION LOADED WITHOUT ERROR MESSAGES, THE PROGRAMMER SHOULD BE "FINE." NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57315 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1