BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2791239 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03500
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 10, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    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): PROGRAMMER WILL INTERROGATE SOME DEVICES CORRECTLY AND WILL DISPLAY AN ERROR WITH OTHER DEVICES. MISSING HANDLE ON PROGRAMMER. KEYBOARD HAS A DAMAGED CONNECTOR. (B)(4) LENS ON RF (RADIO FREQUENCY) HEAD UPPER CASE IS BROKEN. RF HEAD UPLINK FUNCTIONAL TESTS ARE OUT OF SPECIFICATION; THE RF HEAD CABLE IS OUT OF ELECTRICAL SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALTHOUGH THE PROGRAMMER BOOTED UP FINE, WHEN A DEVICE INTERROGATION WAS BEGUN IT DEVELOPED A "HARD" FAILURE AND GENERATED AN ERROR MESSAGE. IT WAS FURTHER NOTED THAT IT WAS SUSPECTED THAT THE RADIO FREQUENCY HEAD HAD AN ISSUE AS WELL (NOT FURTHER DEFINED). BOTH THE PROGRAMMER AND THE HEAD WERE RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAM W/TELEMETRY C PROGRAMMER DXY MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other