BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991807 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02095
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED PROGRAMMER LOCK UP ISSUE; SOFTWARE RECONFIGURED AND RELOADED TO RESOLVE. ANALYSIS ALSO FOUND THE ECG (ELECTROCARDIOGRAM) CONNECTOR IS LOOSE ON THE LEM (LINK ELECTRONIC MODULE) PRINTED CIRCUIT BOARD ASSEMBLY. KEYBOARD IS MISSING SCREW, TAB ON POWER CORD BAY DOOR IS BROKEN, AND SYSTEM FAN IS INTERMITTENTLY NOISY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER WILL NOT COMPLETE BOOT UP PHASE. IT WAS ALSO REPORTED THE PROGRAMMER WON'T GO PAST THE MEDTRONIC SCREEN. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472444 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090AA

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L RADIO FREQUENCY HEAD