BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2811079 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03782
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THE PROGRAMMER RANDOMLY SHUTS OFF DUE TO THE POWER SUPPLY BEING OUT OF ELECTRICAL SPECIFICATION. (B)(4): ANALYSIS FOUND THAT THE DEVICE FAILED THE ELECTROMAGNETIC FIELD IMMUNITY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE PROGRAMMER POWERED DOWN AND WOULD NOT STAY POWERED ON. THE CALLER RAN THE SERVICE DISK, HOWEVER IT DID NOT HELP. THE COMPANY REPRESENTATIVE WAS NOT SURE WHEN THE ISSUE OCCURRED. FOLLOW-UP INDICATED THAT THE COMPANY REPRESENTATIVE WAS AWARE OF THE EVENT TWO MONTHS BEFORE THE DEVICE WAS RETURNED. THE PROGRAMMER WAS RETURNED TO SERVICE FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other