BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 3990030 · Received August 7, 2014

    Report

    Report Number
    2182208-2014-02268
    Event Type
    Injury
    Date Received
    August 7, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE CABLE WAS DAMAGED AND FAILED FUNCTIONAL TESTING. AS A RESULT THE CABLE AND LABEL WERE REPLACED. AFTER THIS THE DEVICE PASSED FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE NOT ABLE TO ESTABLISH TELEMETRY WITH THE IMPLANTED DEVICE. ANOTHER PROGRAMMER WAS TO BE USED. THE PROGRAMMER AND RF HEAD WILL BE RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462717 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention 2090 PROGRAMMER