BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2131642 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00998
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT. (B)(4) RF HEAD UPLINK WAS OUT OF SPECIFICATION. (B)(4) STYLUS AND PRINTER DRAWER FOUND BROKEN. SYSTEM FAN IS NOISY.

    Description of Event or Problem · 1

    IT WAS REPORTED TELEMETRY IS INCONSISTENT, DESPITE CHANGING THE RF HEAD. THE PROGRAMMER AND RF HEAD WERE RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER KRG MEDTRONIC, INC. 2090 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other