BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3860646 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01462
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 11, 2014
    Report Date
    March 6, 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

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND NO SIGNS OF CORROSION FOUND INSIDE OF THE PROGRAMMER. ANALYSIS FOUND THE STYLUS IS DAMAGED; ABLE TO SELECT USING THE BROKEN STYLUS BUT NEED TO BE CAREFUL BECAUSE ONLY A THIN WIRE IS EXPOSED. SYSTEM FAN IS NOISY. PRINTER DRAWER IS MISSING PAPER GUIDE AND PAPER DRAWER IS BROKEN. IT IS NOTED THE PROGRAMMER PASSED FUNCTIONAL TESTING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER WAS LOCATED AT AN ACCOUNT THAT RECENTLY EXPERIENCED A FLOOD FROM A BROKEN WATER PIPE. THE PROGRAMMER SUSTAINED SIGNIFICANT CONTACT WITH WATER AND HAS NOT BEEN TURNED ON OR ATTEMPTED TO BE TURNED ON SINCE THE FLOOD. THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND CALIBRATION, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340380 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD