BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 1162675 · Received September 16, 2008

    Report

    Report Number
    2182207-2008-05808
    Event Type
    Injury
    Date Received
    September 16, 2008
    Report Date
    April 10, 2007
    Manufacturer
    MEDTRONIC INC., NEUROLOGICAL DIVISION
    Product Code
    LKK
    PMA / PMN Number
    P860004/S54
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SENT FOLLOWING AN INTERNAL AUDIT. ADDITIONAL MDR REPORT INVOLVING THE SAME PATIENT AND DEVICE INCLUDE: MDR REPORT NUMBERS: 6000030200700196 AND 2182207200805816.

    Description of Event or Problem · 1

    IN 2007, A NURSE REPORTED THE PATIENTS SYMPTOMS OF BACK AND LEG PAIN WITH NUMBNESS RETURNED FOLLOWING A PREVIOUS CATHETER REVISION (LATE 2006). A REVISION OF THE DISTAL PORTION OF THE CATHETER WAS COMPLETED ON A MONTH PRIOR TO ORIGINAL DATE, RESOLVING THE PATIENT'S SYMPTOMS. PATIENT WAS BEING TREATED WITH LIORESAL, DOSAGE WAS NOT PROVIDED. A CT MYELOGRAM WAS SCHEDULED. THE PAIN THE PUMP WAS PUT IN FOR WAS BEING SUCCESSFULLY TREATED BUT THE CATHETER POSITION ISSUE WAS A CONTINUING PROBLEM FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRATHECAL CATHETER LKK MEDTRONIC INC., NEUROLOGICAL DIVISION 8731 N058715006

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R PROGRAMMER MODEL 8840| LOT# NGP021624N IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL 863720