BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SHUNT

    MDR report key: 1667653 · Received April 23, 2010

    Report

    Report Number
    2021898-2010-00075
    Event Type
    Injury
    Date Received
    April 23, 2010
    Date of Event
    January 11, 1996
    Report Date
    March 24, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THIS REPORTABLE EVENT WAS IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL INFO ON THE DEVICE. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFO PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE, AS NO LOT# WAS PROVIDED. HUSSAIN NS, WANG PP, JAMES C, CARSON BS, AVELLINO AM. DISTAL VENTRICULOPERITONEAL SHUNT FAILURE CAUSED BY SILICONE ALLERGY. CASE REPORT. J NEUROSURG 2005 MARCH; 102(3):536-9.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED A CASE STUDY OF A SINGLE PT WHO HAD A LONG HISTORY OF SHUNT REVISIONS DUE TO A SILICONE ALLERGY THAT REQUIRED A SPECIALLY MFG MEDTRONIC POLYURETHANE SHUNT. THE SHUNT CONSISTED OF AN UNSPECIFIED POLYURETHANE PROXIMAL CATHETER, VALVE MECHANISM, AND DISTAL CATHETER. THE SOURCE LITERATURE REPORTED THAT FOR MORE THAN 8 YRS FOLLOWING THE PLACEMENT OF A POLYURETHANE SHUNT, THE PT HAD NO RECURRENCE OF HYPERSENSITIVITY TO THE SHUNT HARDWARE. HOWEVER, ON (B) (6) 1996, THE PT PRESENTED WITH A HEADACHE DUE TO PROXIMAL OBSTRUCTION THAT REQUIRED A PROXIMAL REVISION. THE PROCEDURE WAS PERFORMED IMMEDIATELY WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SHUNT JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R