BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3993306 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02324
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 18, 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 IT TOOK 1 MINUTE AND 45 SECONDS TO BOOT. ANALYSIS DID NOT REPRODUCE OR CONFIRM THE REPORTED FATAL ERROR. ANALYSIS ALSO FOUND THE VVI BUTTON IS INOPERABLE; VVI PRINTED CIRCUIT BOARD ASSEMBLY REPLACED TO RESOLVE. THE UPPER HINGE PLATE IS CRACKED. LEFT ANTENNA FINAL FUNCTIONAL TEST FAILED; LEFT ANTENNA SECURED TO RESOLVE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FATAL ERROR MESSAGES WERE RECEIVED AND UPON STARTUP THE PROGRAMMER HAS REALLY LONG BOOT. THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469580 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1