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

Model Number UNKNOWN-B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Paralysis (1997); Visual Impairment (2138); Dysphasia (2195); Cognitive Changes (2551); Convulsion/Seizure (4406)

Event Date 03/22/2022

Event Type  Injury  

Event Description

H.Westley phillips, cassia a.B.Maniquis, jia-shu chen, shannon l.Duby, yasunori nagahama, david bergeron, george m.Ibrahim, alexander g.Weil, aria fallah.Midline brain shift after hemispheric surgery: natural history, clinical significance, and association with cerebrospinal fluid diversion.Operative neurosurgery 22 (2022).Doi: 10.1227/ons.0000000000000134.Background: hemispherectomy and its modern variants are effective surgical treatments for medically intractable unihemispheric epilepsy.Although some complications such as posthemorrhoidectomy hydrocephalus are well documented, midline brain shift (mlbs) after hemispheric surgery has only been described anecdotally and never formally studied.Objective: to assess the natural history and clinical relevance of mlbs and determine whether cerebrospinal fluid (csf) shunting of the ipsilateral surgical cavity exacerbates mlbs posthemispheric surgery.Methods: a retrospective review of consecutive pediatric patients who underwent hemispheric surgery for intractable epilepsy and at least 6 months of follow-up at ucla between 1994 and 2018 was performed.Patients were grouped by mlbs severity, shunt placement, valve type, and valve opening pressure (vop).Mlbs was evaluated using the paired samples t-test and analysis of covariance adjusting for follow-up time and baseline postoperative mlbs.Results: seventy patients were analyzed, of which 23 (33%) required csf shunt placement in the ipsilateral surgical cavity for posthemispherectomy hydrocephalus.Mlbs increased between first and last follow-up for nonshunted (5.3 ± 4.9-9.7 ± 6.6 mm, p <(><<)>.001) and shunted (6.6 ± 3.5-16.3 ± 9.4 mm, p <(><<)>.001) patients.Mlbs progression was greater in shunted patients (p =.001).Shunts with higher vops did not increase mlbs relative to nonshunted patients (p =.834), whereas mlbs increased with lower vops (p =.001).Severe mlbs was associated with debilitating headaches (p =.048).Conclusion: patients undergoing hemispheric surgery often develop postoperative mlbs, ie, exacerbated by csf shunting of the ipsilateral surgical cavity, specifically when using lower vop settings.Mlbs exacerbation may be related to overshunting.Severe mlbs is associated with debilitating headaches.Reported events: - mlbs was exacerbated by csf shunting where patients experienced the following mild or severe clinical symptoms: language deficits, motor deficits, sensory deficits, visual deficits, cranial nerve palsies, metabolic/endocrine abnormalities, behavior changes, headaches, persistent/recurrent seizures, and others.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that four patients had adjustable valves.The healthcare professional believed there were no adverse events.

• Brand Name: UNKNOWN NON-DELTA VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18553764
• MDR Text Key: 333379289
• Report Number: 2021898-2024-00061
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-B
• Device Catalogue Number: UNKNOWN-B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• 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 Outcome(s): Other