BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-SHUNT KIT CONTOURED VALVE, REG MED PRESSURE

    MDR report key: 2000979 · Received February 18, 2011

    Report

    Report Number
    2021898-2011-00039
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    November 4, 2010
    Report Date
    January 24, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K841442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS UNAVAILABLE FOR RETURN. THEREFORE,AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE SHIPPING HISTORY SHOWED THE PRODUCT OF LOT C60405 WAS SHIPPED TO DISTRIBUTION CENTERS IN (B)(4). A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. THE STERILIZATION RECORDS FOR LOT C60405 INDICATE THAT ALL PROCESSING PARAMETERS WERE WITHIN SPECIFICATIONS AND ALL SAMPLES PASSES QUALITY TESTING. A REVIEW OF THE COMPLAINT HISTORY SHOWS THAT NO OTHER PRODUCTS IN THIS STERILIZATION BATCH HAVE HAD COMPLAINTS ABOUT INFECTIONS OR THE STERILITY OF THE PRODUCTS. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE STATE THAT LOCAL AND SYSTEMIC INFECTIONS ARE NOT UNCOMMON WITH THIS TYPE OF PROCEDURE AND ARE USUALLY CAUSED BY ORGANISMS THAT INHABIT THE SKIN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY BY A FAMILY MEMBER OF THE PATIENT THAT THE DELTA SHUNT WAS IMPLANTED ON (B)(6) 2010. AFTER THE SURGERY, THE PATIENT GOT AN INFECTION, SO THE DOCTOR EXPLANTED THE SHUNT. THE PATIENT DOUBTED THE AUTHENTICITY OF THE SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-SHUNT KIT CONTOURED VALVE, REG MED PRESSURE JXG MEDTRONIC NEUROSURGERY NA C60405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R