BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 1162674 · Received September 16, 2008

    Report

    Report Number
    2182207-2008-05816
    Event Type
    Injury
    Date Received
    September 16, 2008
    Report Date
    May 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 2182207200805808.

    Description of Event or Problem · 1

    ON 5/21/07, NURSE REPORTED THAT EVEN WITH THE NEW CATHETER PLACEMENT (TWO MONTHS EARLIER), THE PATIENT CONTINUES TO HAVE PAIN AND NUMBNESS IN HER LEGS. THE HCP IS CONSIDERING TROUBLESHOOTING OPTIONS, INCLUDING THE REMOVAL OF THE CATHETER. CURRENTLY, THE PATIENT'S PUMP AND CATHETER ARE IMPLANTED.

    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 Other LOT# NGP021624N IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL 863720| PROGRAMMER MODEL 8840