BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-CARDIAC/PERITONEAL CATHETER, STANDARD, 90CM

    MDR report key: 2172576 · Received July 20, 2011

    Report

    Report Number
    2021898-2011-00166
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K792005
    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. ALTHOUGH THE CATHETER WAS REPORTED, THE COMPLAINT DID NOT RELATED TO A MALFUNCTION OF THIS PART. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. NO IMPACT TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS FOUND LEAKING AFTER BEING EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-CARDIAC/PERITONEAL CATHETER, STANDARD, 90CM JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C70324

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R