BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER

    MDR report key: 2212704 · Received August 11, 2011

    Report

    Report Number
    2021898-2011-00184
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K862303
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. NO INJURY TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PHYSICIAN SUSPECTED THERE WAS A PROBLEM WITH THE CATHETER AND REMOVED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER JXG-SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 11426196

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R