BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951462 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00032
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 27, 2012
    Report Date
    November 27, 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
    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE SYSTEM FAN WAS OUT OF MECHANICAL SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER DID NOT START AND FROZE THE FIRST TIME IT WAS TURNED ON. THE PROGRAMMER WAS RESTARTED AND IT BOOTED UP FINE. WHEN GOING TO THE ANALYZER, THE PROGRAMMER STARTED TO RUN VERY SLOW. EVERY TIME A DIFFERENT FUNCTION WAS TOUCHED ON THE SCREEN, IT TOOK ABOUT TEN SECONDS FOR THE PROGRAMMER TO MAKE THE FUNCTION CHANGE. SOMETIMES IT WOULD REQUIRE THE FUNCTION TO BE HIT TWICE. THE PROGRAMMER WAS AGAIN RESTARTED AND STILL NO CHANGE. ANOTHER PROGRAMMER WAS USED TO FINISH THE CASE. ONCE THE CASE WAS FINISHED, THERE WAS AN ERROR MESSAGE ON THE PROGRAMMER IN QUESTION THAT SAID TO TURN OFF THE PROGRAMMER DUE TO THE POWER SUPPLY WAS OVERHEATING. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56007 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2290 PACING SYSTEM ANALYZER