BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-CATHETER CONNECTOR, STRAIGHT

    MDR report key: 1812807 · Received July 22, 2010

    Report

    Report Number
    2021898-2010-00150
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    May 7, 2010
    Report Date
    June 22, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K831678
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. THE LOT NUMBER REPORTED DID NOT CORRESPOND TO THE REPORTED CATALOG NUMBER. FOLLOW-UP INFO WAS NOT POSSIBLE TO OBTAIN SINCE NO CONTACT INFO WAS PROVIDED. A REVIEW OF THE COMPLAINT HISTORY FOUND NO COMPLAINTS FOR THIS LOT NUMBER. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    (B)(4); IT WAS REPORTED THAT A PT, WITH A HISTORY OF HYDROCEPHALUS, REQUIRED REVISION SURGERY DUE TO SHUNT MALFUNCTION. DURING THE REVISION, THE SURGEON NOTICED THE SHUNT WAS BROKEN AT THE VALVE SITE. THE SURGEON REPORTED THAT THE SHUNT WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-CATHETER CONNECTOR, STRAIGHT JXG MEDTRONIC NEUROSURGERY C52657

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R