BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2791661 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03652
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    September 19, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PROGRAMMER NOTED THE SUPERIOR VENA CAVA COIL (SVC) IMPEDANCE AS GREATER THAN 200 OHMS. THE LEAD IS KNOWN TO NOT HAVE AN SVC COIL. THERE WERE NO LEAD ISSUES REPORTED. THE PROGRAMMER REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF 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 14 YR Other (B)(4) IMPLANTABLE TACHY LEAD