BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2791584 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03528
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 14, 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) - USING A KNOWN GOOD RF (RADIO FREQUENCY) HEAD, TELEMETRY REMAINED STEADY EVEN WHEN THE RF HEAD CONNECTION OF THE PROGRAMMER WAS MOVED BACK AND FORTH. (B)(4) - RF HEAD CABLE IS DAMAGED AT THE POINT WHERE IT ENTERS THE RF HEAD BODY. MOVING THE CABLE AT THIS PART OF THE CABLE CAUSES INTERMITTENT TELEMETRY. THE RF HEAD CABLE UPLINK TESTS ARE OUT OF SPECIFICATION; THE RF HEAD CABLE IS OUT OF ELECTRICAL SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO INTERROGATE SOME DEVICE MODELS. IT WAS NOTED THAT THERE SEEMED TO BE INTERMITTENT TELEMETRY ISSUES WITH RANDOM DEVICES. THE PROGRAMMER WAS RETURNED FOR SERVICE. A SECOND PROGRAMMER WAS AVAILABLE TO COMPLETE THE CHECK. THE RF (RADIO FREQUENCY) HEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE 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