BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4161831 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02639
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 9, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. CONCOMITANT MEDICAL PRODUCTS: 229047 ANALYZER. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE DISPLAY IS INTERMITTENT DUE TO THE INTERPOSE PRINTED CIRCUIT BOARD ASSEMBLY. ANALYSIS ALSO FOUND THE POWER CORD BAY ASSEMBLY LATCH IS BROKEN AND THE POWER SUPPLY FAN IS NOISY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREEN GOES ON AND OFF AND IS NOT INSYNC WITH THE STYLUS PEN. 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
    639521 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD