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

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.

• Brand Name: UNKNOWN VALVE/SHUNT
• Type of Device: SHUNT, 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 Key: 7675024
• MDR Text Key: 113624721
• Report Number: 2021898-2018-00328
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-V
• Device Catalogue Number: UNKNOWN-V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/10/2018
• Supplement Dates Manufacturer Received: 07/03/2018; 08/08/2018
• Supplement Dates FDA Received: 07/10/2018; 10/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention