BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2791490 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03522
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 18, 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 REPORT THAT THE PROGRAMMER HAD NO TELEMETRY. BOTH OF THE LATCHES ON THE POWER CORD DOOR ARE BROKEN. MEDIA BAY DOOR LATCH IS MISSING. (B)(4) RF (RADIO FREQUENCY) HEAD UPLINK AMPLITUDE TESTS ARE OUT OF SPECIFICATION; RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD NO TELEMETRY, AND IT WAS REQUESTED THAT THE WAND, ANALYZER AND PEN BE REPLACED, AND THAT THE PROGRAMMER BE UPGRADED. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2290 PACING SYSTEM ANALYZER