BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-CARDIAC/PERITONEAL CATHETER, STANDARD, 90CM

    MDR report key: 3093678 · Received May 1, 2013

    Report

    Report Number
    2021898-2013-00157
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    February 17, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K792005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN AS IT WAS DISCARDED AT THE HOSPITAL. THEREFORE, AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PT CHECKED INTO THE CLINIC PRESENTING ENDOCRANIAL HYPERTENSION. ACCORDING TO THE REPORT, THE PT WAS LEFT UNDER OBSERVATION, HOWEVER, HE CONTINUED TO PRESENT WITH VOMITING AND DROWSINESS. THE REPORT STATED THAT THEY WERE UNABLE TO PROGRAM THE STRATA VALVE. ACCORDING TO THE REPORT, THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189009 CSF-CARDIAC/PERITONEAL CATHETER, STANDARD, 90CM JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C71770

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| R