BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4832735 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-02106
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    January 23, 2015
    Report Date
    March 6, 2015
    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 IT WAS CONFIRMED THAT THE HEAD WAS ONLY INTERMITTENTLY ABLE TO INTERROGATE DEVICES AND IT FAILED ITS UPLINK TESTS. THE CABLE WAS 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
    376387 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1 2090AA PROGRAMMER