BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4160874 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02785
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED INTERROGATION ISSUE; RF (RADIO FREQUENCY) CONNECTOR FOUND LOOSE ON THE LEM (LINK ELECTRONIC MODULE) PRINTED CIRCUIT BOARD ASSEMBLY BOARD. ANALYSIS ALSO FOUND THE SYSTEM FAN IS NOISY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER DOES NOT RECOGNIZE ANY HIGH OR LOW POWER DEVICES UPON ATTEMPTED INTERROGATION. THE RF (RADIO FREQUENCY) HEADER WAS REMOVED AND REPLACED WITH A NEW ONE AND THE PROGRAMMER FAILED TO INTERROGATE. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642421 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD