BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DELTA VALVE

    MDR report key: 2169628 · Received July 15, 2011

    Report

    Report Number
    2021898-2011-00150
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 1, 2007
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTABLE EVENT WAS IDENTIFIED DURING A REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL 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 AND STERILIZATION RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. PIROTTE B.J.M., ET AL. STERILE SURGICAL TECHNIQUE FOR SHUNT PLACEMENT REDUCES THE SHUNT INFECTION RATE IN CHILDREN: PRELIMINARY ANALYSIS OF A PROSPECTIVE PROTOCOL IN 115 CONSECUTIVE PROCEDURES. CHILDS NERVOUS SYSTEM 2007 AUGUST; 23:1251-1261.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED A REPORT OF A PATIENT WHO DEVELOPED A PERITONEAL INFECTION SECONDARY TO APPENDICITIS SIX MONTHS AFTER THE SHUNT WAS PLACED. NO SHUNT INFECTION WAS FOUND, HOWEVER THE SHUNT WAS EXPLANTED. THE SOURCE LITERATURE REPORTED THAT THE CATHETERS USED WERE NOT MADE BY MEDTRONIC; HOWEVER IT IS POSSIBLE THE PATIENT WAS IMPLANTED WITH A DELTA VALVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R