BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3152557 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01542
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    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

    PRODUCT ID 2090; THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PROGRAMERS WERE UNABLE TO INTERROGATE THE RECENTLY IMPLANTED CARDIAC DEVICE. THE CALLER INDICATED THAT THE PATIENT WAS MOVED TO ANOTHER ROOM, AND ADDED DISTANCE BETWEEN THE DEVICE AND PROGRAMMING HEAD, STILL WITHOUT TELEMETRY POSSIBLE. THE COMPANY REPRESENTATIVE RETRIEVED ANOTHER PROGRAMMER AND WAS ABLE TO INTERROGATE THE DEVICE. AFTER THE SESSION ENDED, THE TWO PROGRAMMERS THAT HAD BEEN TRIED, WERE THEN ABLE TO INTERROGATE THE DEVICE. THE PROGRAMMERS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253168 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR