BEUDAMED
    FDA Adverse Event Death Summary report: N

    CSF - CARDIAC/PERITONEAL CATHETER, STD, BARIUM IMPR

    MDR report key: 2612767 · Received June 7, 2012

    Report

    Report Number
    2021898-2012-00175
    Event Type
    Death
    Date Received
    June 7, 2012
    Date of Event
    November 17, 2009
    Report Date
    May 11, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K792005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. IT WAS NOT CONFIRMED THAT SHUNT MALFUNCTION CAUSED THE BRAIN INJURY AND/OR PATIENT DEATH. IT WAS NOT CONFIRMED THAT THE VALVE IN THE SHUNT SYSTEM WAS A MEDTRONIC NEUROSURGERY PRODUCT. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT "PATIENTS WITH HYDROCEPHALUS SHUNT SYSTEMS MUST BE KEPT UNDER CLOSE OBSERVATION IN THE POSTOPERATIVE PERIOD FOR SIGNS AND SYMPTOMS THAT SUGGEST SHUNT MALFUNCTION. THE CLINICAL FINDINGS MAY INDICATE SHUNT MALFUNCTION. THE CLINICAL FINDINGS MAY INDICATE SHUNT OBSTRUCTION OR OVERDRAINAGE OF CSF." THE INSTRUCTIONS FOR USE ALSO NOTE THAT PERFORATIONS OF THE BOWEL BY THE PERITONEAL CATHETER HAVE BEEN DESCRIBED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT WENT TO THE HOSPITAL THREE TIMES ON (B)(6) 2009 DUE TO NECK PAIN. ACCORDING TO THE REPORT, VP SHUNT DYSFUNCTION WAS NOT DIAGNOSED. THE REPORT STATES THAT ON (B)(6) 2009, THE PATIENT UNDERWENT EMERGENCY SURGERY WHERE IT WAS DISCOVERED THAT THE PERITONEAL CATHETER WAS BLOCKED AND HAD PIERCED THE LARGE BOWEL. ACCORDING TO THE REPORT, THE SHUNT HAD ALSO FRACTURED AT THE "VALVE EXTENSION". IT WAS REPORTED THAT THE PATIENT HAD SUFFERED MASSIVE BRAIN INJURY AND DIED LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF - CARDIAC/PERITONEAL CATHETER, STD, BARIUM IMPR JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY W5729

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death