BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4160522 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02824
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MEDTRONIC INC.
    Product Code
    KRG
    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 THAT THE PROGRAMMER DID NOT PASS IMPEDANCE TESTING AND THE POWER SUPPLY WAS REPLACED TO ADDRESS THE HIGH IMPEDANCE FOR GROUND BOND TESTING. ANALYSIS ALSO CONFIRMED THE NOISY FAN AND IT WAS REPLACED AS WELL AND DETERMINED THAT THE PROGRAMMER'S SCREEN DROPPED AND THEREFORE ITS LOWER DISPLAY HINGES WERE REPLACED.

    Additional Manufacturer Narrative · 1

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

    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 THAT THE PROGRAMMER HAD A LOUD FAN AND THAT DUE TO A HIGH CURRENT DRAIN THE PROGRAMMER DID NOT PASS IMPEDANCE TESTING. 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
    641282 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD