BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3990441 · Received August 7, 2014

    Report

    Report Number
    2182208-2014-02246
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS VERIFIED THE CUSTOMER COMMENT THAT THE PROGRAMMER WOULD NOT POWER UP AND THEREFORE THE LINK ELECTRONIC MODULE BOARD WAS REPLACED AND CALIBRATED. ANALYSIS ALSO FOUND THAT THE DISPLAY WOULD DROP DOWN AND THEREFORE BOTH LOWER HINGES WERE REPLACED. (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 WOULD NOT POWER UP. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT POWER UP. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464917 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC INC. 2090AA

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD