BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3160275 · Received June 10, 2013

    Report

    Report Number
    2182208-2013-01823
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SALES REPRESENTATIVE (SR) THAT TELEMETRY COULD NOT BE ESTABLISHED WITH A PROGRAMMER THAT HAS WORKED IN THE PAST. THE SR STATED THAT NOW THEY COULD ONLY GET TOGGLING BETWEEN THE ORANGE AND ONE GREEN LIGHT ON THE PROGRAMMER. THE SR STATED THAT SOME TROUBLESHOOTING STEPS WERE TAKEN SUCH AS MOVING THE PROGRAMMING HEAD SEVERAL TIMES, BUT THAT DID NOT MAKE A DIFFERENCE. TECHNICAL SUPPORT (TS) SUGGESTED MOVING TO A DIFFERENT ROOM IN CASE THERE IS TOO MUCH INTERFERENCE. TS ALSO SUGGESTED SWAPPING THE PROGRAMMING HEAD, PLACING A TOWEL OVER THE PATIENT¿S PACEMAKER SITE, DOUBLING UP THE MAGNETIC FIELD BY PLACING A DONUT MAGNET UNDER THE PROGRAMMING HEAD WITH OVERWEIGHT PATIENTS OR SLOWLY MOVE THE PROGRAMMING HEAD TOWARD THE PACEMAKER POCKET. THE PROGRAMMER REMAINS 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
    260669 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1