BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2811461 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03689
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 11, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS OVERSENSING OR NOISE. TWO ANALYZER CABLES WERE TRIED, BUT STILL GOT NOISE. THE ANALYZER WAS REBOOTED AND ALL CONNECTIONS WERE DOUBLE CHECKED. THE PHYSICIAN REQUESTED A NEW LEAD BUT THERE WAS STILL NOISE ON THIS LEAD. IT WAS FURTHER REPORTED THE PROBLEM WAS RESOLVED BY REPLACING THE POWER CORD ON THE IMPLANT CART. STATUS OF THE ANALYZER IS UNKNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PACING SYSTEM ANALYZER DXY MEDTRONIC, INC. 2290

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other 5076 IMPLANTABLE PACING LEAD