BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151686 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01286
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC, INC.
    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 EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENTS THAT THE PROGRAMMER RECEIVED NO GREEN LIGHTS UNLESS PRESSURE WAS APPLIED TO THE CONNECTION BETWEEN THE PROGRAMMER AND THE RADIO FREQUENCY PROGRAMMER HEAD AND THE LINK ELECTRONICS MODULE (LEM) BOARD WAS REPLACED AND CALIBRATED. ANALYSIS ALSO FOUND THAT THE SYSTEM FAN WAS NOISY AND IT WAS REPLACED. (B)(4).

    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 ID: 2067 RADIO FREQUENCY PROGRAMMER HEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER RECEIVED NO GREEN LIGHTS WHEN THE RADIO FREQUENCY PROGRAMMER HEAD WAS PLACED OVER THE IMPLANTED HEART DEVICE, UNLESS PRESSURE WAS APPLIED WHERE THE PROGRAMMER HEAD CONNECTED INTO THE PROGRAMMER, THEN IT WORKED AS EXPECTED, HOWEVER ONCE PRESSURE WAS REMOVED THE PROGRAMMER QUIT INTERROGATING AGAIN. THE PROGRAMMER HEAD WAS CHANGED OUT BUT THIS DID NOT RESOLVE THE ISSUE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER RECEIVED NO GREEN LIGHTS WHEN THE RADIO FREQUENCY PROGRAMMER HEAD WAS PLACED OVER THE IMPLANTED HEART DEVICE, UNLESS PRESSURE WAS APPLIED WHERE THE PROGRAMMER HEAD CONNECTED INTO THE PROGRAMMER, THEN IT WORKED AS EXPECTED, HOWEVER, ONCE PRESSURE WAS REMOVED THE PROGRAMMER QUIT INTERROGATING AGAIN. THE PROGRAMMER HEAD WAS CHANGED OUT BUT THIS DID NOT RESOLVE THE ISSUE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252383 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1