BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3990223 · Received August 7, 2014

    Report

    Report Number
    2182208-2014-02256
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    April 28, 2014
    Report Date
    June 2, 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: ANALYSIS DETERMINED THAT THE HEAD WAS NOT FUNCTIONAL, THAT IT CAUSED THE PROGRAMMER TO POWER DOWN WHEN IT WAS PLUGGED INTO THE DEVICE. IT WAS FURTHER NOTED THAT THE HEAD'S CABLE WAS DAMAGED AND THE CABLE WAS REPLACED TO RESOLVE BOTH ISSUES. IT WAS ALSO NOTED THAT THE LENS IN THE UPPER CASE WAS CRACKED AND THEREFORE THE UPPER CASE WAS REPLACED. (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
    464528 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER