BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-LUMBOPERITONEAL CATHETER SYSTEM

    MDR report key: 3952623 · Received July 23, 2014

    Report

    Report Number
    2021898-2014-00260
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K831396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A REVISION PROCEDURE WAS PERFORMED TO REPLACE THE DEVICE DUE TO THE PATIENT EXPERIENCING NUMBNESS, TINGLING, WEAKNESS, AND POSSIBLE IRRITATION OF THE DURA. ACCORDING TO THE REPORT, THE PATIENT HAS MULTIPLE SCLEROSIS (MS), AND THAT THE SYMPTOMS THE PATIENT EXPERIENCED ARE CONSISTENT WITH SYMPTOMS OF MS. THE REPORT STATES THAT THE PHYSICIAN DID NOT SUSPECT THAT THERE WAS A DEFECT OR MALFUNCTION OF THE DEVICE, BUT THAT IT WAS REPLACED IT AS A PRECAUTION TO ENSURE IT WAS NOT CAUSING OR CONTRIBUTING TO THE PATIENT¿S SYMPTOMS. THE REPORT STATES THAT THE PATIENT DID NOT INCUR AN INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431206 CSF-LUMBOPERITONEAL CATHETER SYSTEM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D12288

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R