BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4161061 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02743
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 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 EVENT; THE PROGRAMMER HAS INTERMITTENT INTERROGATION WITH A KNOWN GOOD RF (RADIO FREQUENCY) HEAD; NEED TO POSITION RF (YELLOW) CONNECTOR JUST RIGHT TO INTERROGATE. ABLE TO INTERROGATE WIRELESSLY WITHOUT ISSUE. LOOSE RF CONNECTOR FOUND ON THE LEM (LINK ELECTRONIC MODULE) PRINTED CIRCUIT BOARD ASSEMBLY. ANALYSIS ALSO FOUND A TAB ON POWER CORD BAY DOOR IS BROKEN AND PROGRAMMER DISPLAY ASSEMBLY DROPS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE REAR DOOR CLOSURE OF THE PROGRAMMER NEEDS REPAIR. IT WAS ALSO REPORTED THE YELLOW CONNECTOR IN THE DRAWER FOR PROGRAMMING HEAD REQUIRES MANIPULATION FOR THE PROGRAMMING HEAD TO INTERROGATE; THE CONNECTION IS FAULTY. IT IS NOTED THE PROGRAMMING HEAD OPERATES NORMALLY. 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
    641255 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L RADIO FREQUENCY HEAD