BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1159133 · Received September 12, 2008

    Report

    Report Number
    2182207-2008-05676
    Event Type
    Injury
    Date Received
    September 12, 2008
    Report Date
    August 13, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OTHER = CATHETER.

    Description of Event or Problem · 1

    LITERATURE REFERENCE: SINGH PK, JAIN R, MISHRA S, KUMAR S, BHATNAGAR S, DEO S. MGMT OF PERICATHETER CEREBROSPINAL FLUID LEAK AFTER INTRATHECAL IMPLANTATION OF A DRUG DELIVERY SYS. AM J HOSP PALLIAT CARE. 2008;25(3):237-239. THE CAUSE OF THE CEREBROSPINAL FLUID LEAK AND DIFFERENT TREATMENT APPROACHES ARE DISCUSSED. REPORTABLE EVENT: THIS REPORT PRESENTS A WOMAN, IN WHOM AN INTRATHECAL PUMP SYS WAS INSERTED FOR CANCER PAIN MGMT WITH INTRATHECAL MORPHINE. THIS WAS COMPLICATED BY A PERSISTENT CEREBROSPINAL FLUID LEAK THAT WAS SUCCESSFULLY MANAGED BY PURSE-STRING SUTURES OVER THE DURA AROUND THE CATHETER. WITHOUT REMOVING THE INTRATHECAL IMPLANT. PUMP SYS MFR IS UNK, ADD'L INFO REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK LKK LKK MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R CATHETER MODEL UNK N=1| PROGRAMMER MODEL UNK N=1