BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991465 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02143
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 16, 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

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: DURING ANALYSIS THE PROGRAMMER HEAD WAS OUT OF SPECIFICATION ON ITS UPLINK FUNCTIONAL TESTS AND THEREFORE THE HEAD'S CABLE WAS REPLACED TO RESOLVE. IT WAS ALSO NOTED THAT THE HEAD'S LABEL WAS MISSING ITS BACKING AND THAT THE HEAD'S MAGNET WAS DAMAGED. THE LABEL AND THE MAGNET WERE BOTH REPLACED TO RESOLVE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIOFREQUENCY PROGRAMMER HEAD ORIGINALLY RETURNED AS AN ASSOCIATED DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470909 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER