BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3860674 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01458
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 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

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE PROGRAMMER SCREEN WOULD NOT RESPOND TO THE STYLUS AND THE STYLUS WAS THEREFORE REPLACED AND CALIBRATED. ANALYSIS ALSO FOUND THAT THE KEYBOARD CONNECTOR ON THE MEDIA PROCESSING UNIT WAS LOOSE, THAT THE TAB ON THE POWER CORD BAY DOOR WAS BROKEN AND THAT THE MEDIA BAY DOOR COVER LATCH SPRING WAS BENT. THE MEDIA PROCESSING UNIT, POWER CORD BAY AND MEDIA BAY DOOR COVER WERE REPLACED TO RESOLVE. (B)(4).

    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

    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 SCREEN WOULD NOT RESPOND TO THE STYLUS. THE CALLER REPLACED THE STYLUS, BUT THAT DID NOT RESOLVE THE ISSUE. THE PROGRAMMER WILL BE RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER SCREEN WOULD NOT RESPOND TO THE STYLUS. THE CALLER REPLACED THE STYLUS, BUT THAT DID NOT RESOLVE THE ISSUE. THE PROGRAMMER WILL BE RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339396 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1