BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2790405 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03454
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    June 1, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    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 COULD NOT CONFIRM THE REPORTED EVENT. PROGRAMMER WAS LEFT ON WITH THE HEAD PLUGGED IN FOR OVER 24 HOUR WITH NO FAULT FOUND. THERMAL SENSOR #6 FUNCTIONAL TEST IS OUT OF SPECIFICATION; LVDS (LOW VOLTAGE DIFFERENTIAL SIGNAL) PRINTED CIRCUIT BOARD FOUND OUT OF ELECTRICAL SPECIFICATION. STYLUS IS BENT. RIGHT KEYBOARD HINGE IS DAMAGED. POWER SUPPLY HAS CORROSION. (B)(4) RF (RADIO FREQUENCY) HEAD UPLINK TESTS ARE OUT OF SPECIFICATION; RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. RF HEAD LABEL BACKING MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS INTERMITTENTLY OVERHEATING. THE PROGRAMMER WAS RETURNED FOR SERVICE. THE RF (RADIO FREQUENCY) HEAD WAS RETURNED TO THE MANUFACTURER, 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
    1 CARELINK PROGRAMMER RF HEAD KRG MEDTRONIC, INC. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other