BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHUNT

    MDR report key: 1671442 · Received April 28, 2010

    Report

    Report Number
    2021898-2010-00072
    Event Type
    Injury
    Date Received
    April 28, 2010
    Date of Event
    December 1, 2008
    Report Date
    March 24, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 PT INFO. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL INFO 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 FOR CSF SHUNTING PROCEDURES. RAMMOS S, KLOPFENSTEIN J, AUGSPURGER L ET AL. CONVERSION OF EXTERNAL VENTRICULAR DRAINS TO VENTRICULOPERITONEAL SHUNTS AFTER ANEURYSMAL SUBARACHNOID HEMORRHAGE: EFFECTS OF SITE AND PROTEIN/RED BLOOD CELL COUNTS ON SHUNT INFECTION AND MALFUNCTION. J NEUROSURG 2008 DECEMBER; 109(6); 1001-4.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED A STUDY OF 80 SUBJECTS WITH CSF SHUNTS. THE SHUNTS CONSISTED OF UNSPECIFIED MEDTRONIC VALVES AND COMPETITOR CATHETERS. THE SOURCE LITERATURE REPORTED THE FOLLOWING EVENTS: 3 SHUNT REVISIONS DUE TO OBSTRUCTION, 1 SHUNT REVISION DUE TO PERITONEAL PLACEMENT, AND 1 SHUNT REVISION DUE TO KINKING OF THE DISTAL CATHETER.

    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 61 YR Hospitalization| R