BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 2790572 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03467
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    June 13, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED EVENT, NO ANOMALIES WERE FOUND. (B)(4): ANALYSIS FOUND THAT THE DEVICE FAILED TELEMETRY TESTING DUE TO THE CABLE BEING OUT OF ELECTRICAL SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE MIDDLE OF A CASE THE ANALYZER STOPPED SENSING AND PACING, ALTHOUGH THE PROGRAMMER WAS PLUGGED IN. ANOTHER PROGRAMMER WAS AVAILABLE AND THE CASE WAS ABLE TO BE COMPLETED. THE ANALYZER AND PROGRAMMER WERE RETURNED FOR SERVICE. THE RADIOFREQUENCY (RF) HEAD WAS ALSO RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2090 PROGRAMMER