BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2953689 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00347
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 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 WHILE TRYING TO INTERROGATE AN IMPLANTED DEVICE THE PROGRAMMER DISPLAYED AN ERROR MESSAGE INDICATING "INCOMPATABLE SOFTWARE." OTHER PROGRAMMERS WERE TRIED WITH THE SAME RESULT. THE DEVICE HAD BEEN SUCCESSFULLY INTERROGATED PREVIOUSLY AT ANOTHER LOCATION. TECHNICAL SERVICES SUGGESTED THAT THE PROGRAMMER PREVIOUSLY USED BE TRIED. ADDITIONAL INFORMATION OBTAINED THROUGH FOLLOW UP INDICATED THAT THE DEVICE WAS SUCCESSFULLY INTERROGATED WITH ANOTHER PROGRAMMER. THE STATUS OF THE PROGRAMMER 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
    56499 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1