BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA OR DELTA VALVES

    MDR report key: 2223833 · Received August 18, 2011

    Report

    Report Number
    2021898-2011-00196
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    August 1, 2005
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K012052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THESE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. THE EVENTS REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCTS WERE 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. THE CORRESPONDING AUTHOR STATED THAT SHUNT INFECTION IS A KNOWN RISK OF SURGERY AND NOT RELATED TO VALVE IMPLANT. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. JALLO G.I. ET AL. EFFECT OF ANTIBIOTIC-IMPREGNATED SHUNT CATHETERS IN DECREASING THE INCIDENCE OF SHUNT INFECTION IN THE TREATMENT OF HYDROCEPHALUS. JOURNAL OF NEUROSURGERY (PEDIATRICS 2) 2005 AUGUST; 103:131-136.

    Description of Event or Problem · 1

    A REVIEWED LITERATURE ARTICLE CONTAINED A STUDY OF 211 PATIENTS THAT UNDERWENT 353 SHUNT PLACEMENT PROCEDURES. EIGHTY-FIVE PERCENT OF THE SHUNT SYSTEMS INCLUDED MEDTRONIC STRATA AND DELTA VALVES. THE SOURCE LITERATURE REPORTED TWENTY SEVEN CASES OF SHUNT INFECTION. THE ARTICLE DID NOT COMMENT ON HOW MANY MEDTRONIC VALVES RESULTED IN REVISION DUE TO INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R