BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991062 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02190
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 DID NOT REPRODUCE THE CUSTOMER EXPERIENCE OF ERRORS HOWEVER THEY WERE CONFIRMED IN THE ERROR LOG AND THE HARD DRIVE WAS REPLACED AND REIMAGED AND THE POWER SUPPLY REPLACED AS PREVENTIVE. ANALYSIS DID FIND THAT THE PAPER GUIDE ON THE PRINTER DRAWER WAS BROKEN AND THAT THE PROGRAMMER HAD AN INCORRECT MEDIA BAY DOOR AND A NOISY SYSTEM FAN. ALL WERE REPLACED. (B)(4).

    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 THAT THE PROGRAMMER GENERATED ERRORS THREE TIMES, ONE ACCOMPANIED AN AUTOMATIC SHUT DOWN. DESPITE THE POWER BEING RECYCLED AND THE SERVICE DISK BEING RUN, ANOTHER ERROR OCCURRED. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER GENERATED ERRORS THREE TIMES, ONE ACCOMPANIED AN AUTOMATIC SHUT DOWN. DESPITE THE POWER BEING RECYCLED AND THE SERVICE DISK BEING RUN, ANOTHER ERROR OCCURRED. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468205 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1