BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2791286 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03505
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 10, 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): THE RF (RADIO FREQUENCY) HEAD HAS NO TELEMETRY AND THE DEVICE IS OUT OF SPECIFICATION ON UPLINK FUNCTIONAL TESTS; THE RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. RF HEAD IS MISSING LABEL BACKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE SEEMED TO BE AN ISSUE WITH THE CORD ON THE RADIO FREQUENCY HEAD WHERE IT IS CONNECTED INTO THE PROGRAMMER. SOMETIMES THE HEAD WORKED AND SOMETIMES IT DID NOT. TO GET IT TO WORK, THE CORD HAD TO BE MOVED AT THE CONNECTION. THE HEAD 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. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other