BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHUNT

    MDR report key: 1667478 · Received April 23, 2010

    Report

    Report Number
    2021898-2010-00071
    Event Type
    Injury
    Date Received
    April 23, 2010
    Date of Event
    December 1, 1999
    Report Date
    March 24, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THESE REPORTABLE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE AND PATIENT INFORMATION. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL INFORMATION ON INDIVIDUAL EVENTS. THE EVENTS REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE DESCRIBED FAILURE RATE WAS WITHIN EXPECTED RANGES FOR CSF SHUNTING PROCEDURES. POLLACK IF, ALBRIGHT AL, ADELSON PD. A RANDOMIZED, CONTROLLED STUDY OF A PROGRAMMABLE SHUNT VALVE VERSUS A CONVENTIONAL VALVE FOR PATIENTS WITH HYDROCEPHALUS. HAKIM-MEDOS INVESTIGATOR GROUP. NEUROSURGERY 1999 DECEMBER;45(6):1399-408.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED A CONTROL GROUP OF 183 SUBJECTS WITH CSF SHUNTS. THE SHUNTS CONSISTED OF UNSPECIFIED MEDTRONIC DELTA-TYPE VALVES, OTHER MEDTRONIC VALVES, COMPETITOR VALVES, AND UNKNOWN CATHETERS. THE SOURCE LITERATURE REPORTED THAT 71 OF THE 183 VALVES REQUIRED EXPLANTATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R