BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991802 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02092
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 12, 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 UPLINK FUNCTIONAL TESTS WERE OUT OF SPECIFICATION AND THEREFORE THE CABLE WAS REPLACED TO RESOLVE. ANALYSIS ALSO DETERMINED THAT THE LENS IN THE UPPER CASE WAS CRACKED AND THAT THE LABEL BACKING WAS MISSING. BOTH THE UPPER CASE AND THE LABEL WERE REPLACED TO RESOLVE. CONCOMITANT PRODUCT: PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE RADIOFREQUENCY PROGRAMMER HEAD WHICH WAS 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
    467207 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 2090W PROGRAMMER