BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN VALVE/SHUNT

    MDR report key: 8579762 · Received May 3, 2019

    Report

    Report Number
    2021898-2019-00169
    Event Type
    Death
    Date Received
    May 3, 2019
    Date of Event
    June 28, 2017
    Report Date
    May 3, 2019
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CHIH-WEI HUNG, WEI-CHE LIN, WEN-NENG CHANG, TSUNG-MING SU, CHIA-TE KUNG, NAI-WEN TSAI, HUNG-CHEN WANG, CHIH-CHENG HUANG, BEN-CHUNG CHENG, YU-JIH SU, YA-TING CHANG, CHIH-MIN SU, SHENG-YUAN HSIAO, CHENG-HSIEN LU. RISK FACTORS AND OUTCOMES OF CEREBROSPINAL FLUID OVERDRAINAGE IN HIV-NEGATIVE PATIENTS WITH CRYPTOCOCCAL MENINGITIS AFTER THE VENTRICULOPERITONEAL SHUNTING PROCEDURE. JOURNAL OF MICROBIOLOGY 51 (2018). DOI: 10.1016/J.JMII.2017.06.002 ABSTRACT PURPOSE: SHUNT PROCEDURES USED TO TREAT CRYPTOCOCCAL MENINGITIS COMPLICATED WITH HYDROCEPHALUS AND/OR INCREASED INTRACRANIAL PRESSURE (IICP) COULD RESULT IN CEREBROSPINAL FLUID (CSF) OVERDRAINAGE, THEREBY PRESENTING THERAPEUTIC CHALLENGES. METHODS: WE ANALYZED THE CLINICAL FEATURES AND NEUROIMAGING FINDINGS AFTER THE VENTRICULOPERITONEAL (VP) SHUNT PROCEDURE IN 51 HIV (HUMAN IMMUNODEFICIENCY VIRUS)-NEGATIVE PATIENTS WITH CRYPTOCOCCAL MENINGITIS, TO ASSESS THE RISK FACTORS ASSOCIATED WITH POST-SHUNT CSF OVERDRAINAGE. RESULTS: SYMPTOMATIC CSF OVERDRAINAGE OCCURRED IN 12% (6/51) OF PATIENTS WITH CRYPTOCOCCAL MENINGITIS WHO UNDERWENT THE SHUNT PROCEDURE. RAPID DETERIORATION OF NEUROLOGICAL CONDITIONS WAS FOUND IN 6 PATIENTS AFTER THE SHUNT PROCEDURE WAS PERFORMED, INCLUDING DISTURBED CONSCIOUSNESS, QUADRIPARESIS, AND DYSPHASIA IN 5 PATIENTS AND SEVERE ATAXIA IN 1. THE MEAN DURATION OF CSF OVERDRAINAGE AFTER THE SHUNTING PROCEDURE WAS 2-7 DAYS (MEAN 4 DAYS). THE MEAN INTERVAL BETWEEN MENINGITIS ONSET TO SHUNTING PROCEDURE REMAINED INDEPENDENTLY ASSOCIATED WITH CSF OVERDRAINAGE, AND THE CUT-OFF VALUE FOR PREDICTING CSF OVERDRAINAGE IN INTERVAL BETWEEN MENINGITIS ONSET TO SHUNTING PROCEDURE WAS 67.5 DAYS. CONCLUSIONS: CSF OVERDRAINAGE AFTER THE VP SHUNT PROCEDURE IS NOT RARE, ESPECIALLY IN PATIENTS WITH A HIGH-RISK OF CRYPTOCOCCAL MENINGITIS WHO ALSO HAVE A PROLONGED DURATION OF HYDROCEPHALUS AND/OR IICP. REPORTED EVENTS. AMONG THE 51 PATIENTS WHO UNDERWENT THE SHUNT PROCEDURE, 49 OF THE PATIENTS HAD A MEDTRONIC SHUNT. 6 OUT OF 6 PATIENTS WITH MEDTRONIC SHUNTS EXPERIENCED OVERDRAINAGE. 43 OUT OF 45 PATIENT WITH MEDTRONIC SHUNTS EXPERIENCED NO OVERDRAINAGE. NEUROLOGICAL CONDITIONS DETERIORATED RAPIDLY (WITHIN 1 WEEK) IN THE 6 PATIENTS WHO HAD CSF OVERDRAINAGE AFTER HAVING UNDERGONE THE SHUNTING PROCEDURE. THE CLINICAL FEATURES OF THE PATIENTS WITH CSF OVERDRAINAGE INCLUDE 4 FEVER/CHILLS, 5 HEADACHE, AND 4 DISTURBED CONSCIOUSNESS AT EMERGENCY ROOM. THE NEUROIMAGING FINDINGS OF PATIENTS WITH CSF OVERDRAINAGE INCLUDED 1 CEREBRAL INFARCTION, 1 GYRAL ENHANCEMENT, 1 BASAL CISTERN EFFACEMENT, 1 PSEUDO-CYST, AND 2 DILATED VIRCHOW-ROBIN SPACE. FOLLOW-UP NEUROIMAGING STUDIES IN THE 6 PATIENTS WHO HAD OVERDRAINAGE AFTER THE SHUNT PROCEDURE SHOWED THIN-LAYER SUBDURAL EFFUSION IN BOTH HEMISPHERES. THE SYMPTOMS OBSERVED IN THESE 6 PATIENTS WERE DISTURBED CONSCIOUSNESS AND ACUTE QUADRIPARESIS WITH DYSPHASIA IN 5 PATIENTS, AND SEVERE ATAXIA IN 1. IN ADDITION, THE EFFECT ON VENTRICULAR RELIEF ON THE 6 PATIENTS WHO EXPERIENCED OVERDRAINAGE INCLUDE UNSTEADY GAIT, DROWSINESS, AND FRONTOPARIETAL SUBDURAL HEMORRHAGE. THE TIME DURATION BETWEEN THE COMPLETION OF SHUNT PROCEDURE AND WHEN THE NEW SYMPTOMS FIRST APPEARED WAS 2-7 DAYS (MEAN, 4 DAYS). TO TREAT CSF OVERDRAINAGE, THE VP SHUNTS WERE LIGATED IN 4 PATIENTS, AND THE SHUNTS WERE REVISED IN 2 PATIENTS. 5 OUT OF THE 6 PATIENTS WITH OVERDRAINAGE HAD A GOOD RECOVERY, AND 1 OUT OF THE 6 PATIENTS WITH OVERDRAINAGE DIED. THE CLINICAL FEATURES OF THE PATIENTS WITHOUT CSF OVERDRAINAGE INCLUDE 25 FEVER/CHILLS, 24 HEADACHE, 20 DISTURBED CONSCIOUSNESS AT EMERGENCY ROOM, 7 VISUAL DISTURBANCE, AND 5 HEARING IMPAIRMENT. THE NEUROIMAGING FINDINGS OF PATIENTS WITHOUT CSF OVERDRAINAGE INCLUDED 7 CEREBRAL INFARCTION, 7 GYRAL ENHANCEMENT, 3 BASAL CISTERN EFFACEMENT, 3 PSEUDO-CYST, AND 3 DILATED VIRCHOW-ROBIN SPACE AND 4 MASS LESIONS. 15 OUT OF THE 45 PATIENT WITH NO OVERDRAINAGE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373441 UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-V UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| H| R