BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_PUMP

    MDR report key: 3241465 · Received July 22, 2013

    Report

    Report Number
    3007566237-2013-02435
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿THE INSIDE GOT BAD BECAUSE THERE WAS SOMETHING CLOGGING THE TIP¿. THE PATIENT WAS UNSURE WHAT THE CLOG WAS AND WHEN THE EVENT OCCURRED; HOWEVER, STATED THE EVENT MAY HAVE OCCURRED IN 2007. THE PATIENT¿S CATHETER WAS SURGICALLY REPLACED. NO PATIENT SYMPTOMS WERE REPORTED. THE DEVICE SYSTEM DELIVERED MORPHINE AND CLONIDINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED CONFLICTING INFORMATION. IT WAS REPORTED THAT THE EVENT OCCURRED IN 2011. A CATHETER DYE STUDY WAS DONE ON (B)(6) 2011 WITH RESULTS REPORTED AS "NORMAL." IT WAS NOTED THAT SURGERY HAD NOT BEEN DONE. THE PUMP WAS STILL IN AT THE TIME OF REPORT. THE PAIN WAS BEING WELL CONTROLLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339983 UNKNOWN_PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention