BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2811901 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03672
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    August 27, 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) PROGRAMMER DOES NOT POWER ON; POWER SUPPLY FOUND OUT OF ELECTRICAL SPECIFICATION. SYSTEM FAN IS NOISY. PROGRAMMER MICROPHONE FOUND OUT OF ELECTRICAL SPECIFICATION. (B)(4) RF (RADIO FREQUENCY) HEAD WILL NOT INTERROGATE; RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ANALYZER SESSION WENT TO BE ENTERED AN ERROR MESSAGE APPEARED ON THE PROGRAMMER THAT THERE WAS NO ANALYZER CONNECTION. IT WAS FURTHER NOTED THAT THE PROGRAMMER WAS POWERED OFF AND IT WAS UNABLE TO BE POWERED ON. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. THE RF (RADIO FREQUENCY) HEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION.

    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