BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3860084 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01526
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 14, 2014
    Report Date
    March 21, 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 CONFIRMED THAT THE DEVICE WAS BROKEN. THE DEVICE FAILED UPLINK AMPLITUDE TESTING DUE TO THE CABLE BEING OUT OF ELECTRICAL SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIOFREQUENCY PROGRAMMER HEAD WAS BROKEN, AND IT WAS FURTHER NOTED THAT IT WAS NOT NEEDED BACK. THE PROGRAMMER HEAD WAS RETURNED FOR SERVICE. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339721 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1