BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3160278 · Received June 10, 2013

    Report

    Report Number
    2182208-2013-01814
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SALES REPRESENTATIVE (SR) THAT THE PROGRAMMER DISPLAYED A MESSAGE CONCERNING NOISE DURING A DEVICE INTERROGATION, AND TO MOVE THE RADIO FREQUENCY (RF HEAD) AND RE-INTERROGATE. THE SR INTERROGATED THE DEVICE MANY TIMES UNTIL 100% INTERROGATION WAS ACHIEVED AND THE SESSION WAS COMPLETED. TECHNICAL SUPPORT (TS) LEFT A VOICEMAIL FOR THE SR EXPLAINING THAT THERE COULD BE EXTERNAL NOISE AT THAT LOCATION OR THERE COULD BE A BAD RF HEAD OR CONNECTION THAT COULD CAUSE NOISE. IF IT CONTINUES TO HAPPEN, THE PROGRAMMER WOULD NEED TO BE SEEN BY THE SERVICE DEPARTMENT. 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
    260670 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG. 2090AA

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 PROGRAMMER RADIO FREQUENCY (RF) HEAD