BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-PERITONEAL CATHETER, STD, OPEN END W/ WALL SLITS, 90CM

    MDR report key: 2111702 · Received May 25, 2011

    Report

    Report Number
    2021898-2011-00086
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K841442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIVE CENTIMETERS OF CATHETER WAS RETURNED. THE PERITONEAL CATHETER PASSED THE PATENCY CHECK. HOWEVER, PROTEINACEOUS DEBRIS WAS NOTED ON THE INTERIOR OF THE CATHETER. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT THE SYSTEM MAY BECOME INTERNALLY OCCLUDED DUE TO TISSUE FRAGMENT, BLOOD CLOTS, TUMOR CELL AGGREGATES, BACTERIAL COLONIZATION, OR OTHER DEBRIS. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A SHUNT REVISION WAS PERFORMED. ACCORDING TO THE REPORT, THE DISTAL END OF THE CATHETER WAS OCCLUDED. ONCE THE DOCTOR CUT OFF THIS PORTION OF THE CATHETER, THE SHUNT WORKED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-PERITONEAL CATHETER, STD, OPEN END W/ WALL SLITS, 90CM JXG MEDTRONIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R