BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SYSTEM

    MDR report key: 2131920 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00926
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/102
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. THE CHANGE IS REFLECTED IN THIS REPORT UNDER SECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN VIEWING THE PATIENT TRANSMISSION REPORT IN THE CARELINK NETWORK ON ATRIAL HIGH RATE EPISODE EGM THE DATA APPEARS IN SYMBOLS IN THE HEADER AND MARKER CHANNEL RATHER THAN THE EXPECTED DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK SYSTEM SOFTWARE NVZ MEDTRONIC, INC. CARELINK CONGO ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR| 4524 IMPLANTABLE PACING LEAD| 4024 IMPLANTABLE PACING LEAD| 4524 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| 4024 IMPLANTABLE PACING LEAD