BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2791404 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03516
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 13, 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 CONFIRMED THE REPORTED EVENT. ECG (ELECTROCARDIOGRAM) CONNECTOR IS LOOSE. POWER CORD DOOR IS BROKEN. PROGRAMMER HANDLE IS BROKEN. (B)(4) NOT ABLE TO INTERROGATE NON WIRELESS DEVICES. RF (RADIO FREQUENCY) HEAD CABLE IS SEVERELY TWISTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD TROUBLE INTERROGATING NON-WIRELESS DEVICES AND THAT IT ONLY INTERMITTENTLY LOCATED THE DEVICES. 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 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. 2067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2290 PACING SYSTEM ANALYZER