BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER

    MDR report key: 2181296 · Received July 21, 2011

    Report

    Report Number
    2021898-2011-00171
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 9, 2009
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTABLE EVENT WAS IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE CORRESPONDING AUTHOR STATED THAT THE EVENT IS GENERALLY ATTRIBUTED TO LOW GRADE ABDOMINAL INFECTION WHICH IS INDEPENDENT OF CATHETER TYPE OR MANUFACTURER. NO IMPACT TO PATIENT REPORTED. REIG A.S., ET AL. CT-BASED, FIDUCIAL-FREE FRAMELESS STEREOTAXY FOR DIFFICULT VENTRICULOPERITONEAL SHUNT INSERTION: EXPERIENCE IN 26 CONSECUTIVE PATIENTS. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY 2010 JANUARY ; 88:75-80.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED A REPORT OF A PATIENT WHO DEVELOPED AN ABDOMINAL PSEUDOCYST REQUIRING TEMPORARY EXTERNALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CATHETER JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R