BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MNS UNKNOWN CATHETER

    MDR report key: 3233445 · Received July 18, 2013

    Report

    Report Number
    2021898-2013-00234
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY 9.5 CM OF THE VENTRICULAR CATHETER WAS RETURNED. THE RETURNED CATHETER MET THE SPECIFICATIONS FOR PATENCY AND LEAK TESTING. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD AN ENZYME DEFICIENCY CALLED MPS. ACCORDING TO THE REPORT, THE PATIENT HAD A LARGE BUILD-UP OF GAGS. THE REPORT STATED THAT SHUNT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334174 MNS UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| R