MAUDE Adverse Event Report: MEDTRONIC DOMINICANA CSF-FLOW CONTROL VALVE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42314
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding a shunt.It was reported the patient was recovering from a brain tumor (medulloblastoma).It was stated the device was externalized as the patient was going through radiotherapy.They were going to internalize it maybe on (b)(6) 2025.This was clarified indicating that the shunt was still in place and that the exit was out of the abdomen to a bag.It was indicated the patient had cerebral mutism and was unable to communicate but sometimes maybe slight head nod to yes/no questions.The patient was also having problems with over or under draining as they were having slit ventricles, then huge ventricles.They have not found a decent drain open schedule.It was indicated that the patient has had multiple post operative problems.10 weeks after the medulloblastoma was removed, the patient was still minimally responsive.Every ct scan showed enlarged or slit ventricles.The patient now had multiple blood clots in their cerebral vessels.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CSF-FLOW CONTROL VALVE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 22418507
• Report Number: 9612501-2025-01704
• Device Sequence Number: 8663299
• Product Code: JXG
• UDI-Device Identifier: 00763000028015
• UDI-Public: (01)00763000028015(17)290327(10)0228717372
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• PMA/510(K) Number: K841442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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
• Operator of Device: Health Professional
• Device Model Number: 42314
• Device Catalogue Number: 42314
• Device Lot Number: 0228717372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/07/2025
• Date Device Manufactured: 04/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 31 KG