• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-V
Device Problems Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)
Patient Problems Headache (1880); Hepatitis (1897); Unspecified Infection (1930); Muscle Weakness (1967); Nausea (1970); Neurological Deficit/Dysfunction (1982); Therapeutic Effects, Unexpected (2099); Weakness (2145); Fungal Infection (2419); Ambulation Difficulties (2544); Hydrocephalus (3272)
Event Type  Injury  
Event Description
See attached literature article.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Kaveh barami, indro chakrabarti, james silverthorn, jeremy ciporen, paul t. Akins. Diagnosis, classification, and management of fourth ventriculomegaly in adults: report of 9 cases and literature review. World neurosurgery (2018). Doi: 10. 1016/j. Wneu. 2018. 05. 073 - objective: an enlarged fourth ventricle, otherwise known as fourth ventriculomegaly (4th vm), has been reported previously in the pediatric population, yet literature on adults is scant. We report our experience with 4th vm in adults over an 11-year period and review the literature. - materials and methods: this was a retrospective chart review of adult patients with the diagnosis of 4th vm admitted to the intensive care unit in a tertiary care center. - results: nine patients were identified with 4th vm. Most presented with symptoms in the posterior fossa. Five cases were related to previous shunting and the underlying neurosurgical diseases, and average time interval to develop symptoms was 5. 3 years. We divided our cases into primary, acquired, and degenerative based on the pathophysiology involved. Treatments included extended subzero cerebrospinal fluid diversion using a frontal external ventricular drain followed by low-pressure shunt revision, endoscopic third ventriculostomy, suboccipital decompression, and fourth ventricular catheter placement. Literature review identified additional published cases, and there were no reports of a formal classification scheme or treatment algorithm. - conclusions: this case series illustrates a narrow spectrum of etiologies associated with 4th vm in adults. We propose a simple classification scheme dividing 4th vm into 3 categories: primary, acquired, and degenerative. We recommend a stepwise treatment approach starting with extended subzero cerebrospinal fluid diversion followed by shunting for symptomatic primary and acquired 4th vm. Lower success rates and greater morbidity are associated with rescue procedures such as fourth ventricle drainage catheters, endoscopic third ventriculostomies, and skull base decompression. Reported events. A (b)(6) male patient with liver cirrhosis due to hepatitis c infection and coccidioidomycosis developed communicating hydrocephalus and underwent vps placement and treatment with intrathecal amphotericin at an outside hospital. At (b)(6), he presented to our emergency department with headache, nausea, and generalized weakness. Ct of the head demonstrated generalized ventricular enlargement. His shunt was externalized as the distal catheter was occluded with positive cultures for coccidioidomycosis. His antifungal therapy was escalated. He was diagnosed with low-pressure hydrocephalus, which improved with subzero drainage. He ultimately required bilateral vps placement. At (b)(6), he developed gait sixth and seventh cranial nerve deficits and gait imbalance. Ct of the head showed 4th vm. Mri showed patent foramen of luschka and increased enhancement of the basilar meninges, enlarged fourth ventricle, and craniocervical crowding. He underwent chiari decompression and placement of a fourth-ventricle catheter. He was switched from fluconazole to voriconazole antifungal therapy. He has remained clinically stable for 3 years.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN VALVE/SHUNT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key7675024
MDR Text Key113624721
Report Number2021898-2018-00328
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-V
Device Catalogue NumberUNKNOWN-V
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/10/2018 Patient Sequence Number: 1
-
-