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

Model Number UNKNOWN-S

Device Problem Insufficient Information (3190)

Patient Problems Vertigo (2134); Dysphasia (2195)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event Description

Hassan a.Khayat, tariq al-saadi, valerie panet-raymond, roberto jose diaz.Surgical management of isolated fourth ventricular hydrocephalus associated with injury to the guillain-mollaret triangle.World neurosurgery 122 (2019).Doi: org/10.1016/j.Wneu.2018.10.091.Background: the occurrence of isolated fourth ventricle and injury to the guillain-mollaret triangle in the setting of posterior fossa ependymoma represents a new association.In this case report, we discuss the clinical, theoretical, and therapeutic aspects of this problem.We describe a lateral transcerebellar trajectory and shunt valve configuration for safe fourth ventricle shunting in a patient with prior posterior fossa surgery.Case description: a (b)(6)-year-old woman underwent subtotal resection of a fourth ventricle ependymoma (world health organization grade iii) followed by radiation therapy to control the residual tumor.Her course was complicated by a cerebral abscess and subsequent communicating hydrocephalus, for which she received a lateral ventriculoperitoneal shunt.After placement of the lateral ventricle shunt, there was a progressive increase in the volume of the fourth ventricle over the next 2 years, from 2.5 to 12.0 ml.She developed palatal myoclonus, hand incoordination, bilateral foot numbness, and progressive ataxia.Neuroimaging also revealed hypertrophic degeneration of the inferior olivary nuclei bilaterally.The isolated fourth ventricle was treated by a separate fourth ventriculoperitoneal shunt inserted through a lateral transcerebellar trajectory.A programmable variable pressure valve was implemented.Conclusions: development of an isolated fourth ventricle and injury to the guillain-mollaret triangle in the setting of fourth ventricular ependymoma is a newly encountered complication.Choice of treatment modality and timing of intervention should be carefully considered on a case-by-case basis.The data presented in this report may assist in the selection of surgical treatment for isolated fourth ventricle.Reported events.After the insertion of a separate fourth ventriculoperitoneal shunt (strata ii set at 1.5) to drain the fourth ventricle, although the (b)(6) year old female's speech is improved, she is still having dysarthria with a scanning quality speech.The vertigo is also unchanged.

• Brand Name: UNKNOWN STRATA 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: 8188519
• MDR Text Key: 131922356
• Report Number: 2021898-2018-00582
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR