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

Model Number	42314
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Medtronic received information regarding a valve.It was reported that the doctor was placing ventriculoperitoneal shunt, however, it started leaking as soon as they put it in.The doctor removed it and placed a new one without problem.
Event or Problem Description
Medtronic received information regarding a valve/shunt.It was reported that per provider documentation, the ventricular catheter was passed easily into the right lateral ventricle.The ventricular catheter stylet was removed and brisk flow of cerebrospinal fluid (csf) was noted.The ventricular catheter was confirmed at a depth of 5.5cm at the outer table.The ventricular catheter was then connected to the valve.The valve was a medium pressure small size valve (non-programmable, fixed pressure).The connections at the proximal and distal valve stems were reinforced with 2-0 silk ties.The valve was secured to the pericranium with two 4-0 nurolon sutures.After the valve was secured, it was noted to be be leaking csf briskly out of the proximal end (between the valve stem and the reservoir).Therefore, the valve was removed and replaced.After the new valve was placed, there was no obvious leaking of csf from the valve, however, the ventricular catheter appeared to be leaking (likely from all the prior manipulation).Therefore, the catheter was removed and a new bactiseal ventricular catheter was soft passed into the ventricle to the same depth.This was then secured to the new valve with a 2-0 silk tie.There was no obvious leaking from the valve or the catheters after that.
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.
Additional Manufacturer Narrative
H3.Product analysis determined that the returned valve failed leak testing requirements due to a cut found at the bottom of the reservoir dome at the stem.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: 24160260
• Report Number: 9612501-2026-00166
• Device Sequence Number: 9129652
• Product Code: JXG
• UDI-Device Identifier: 00763000028015
• UDI-Public: (01)00763000028015(17)291216(10)0230391735
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: 42314
• Device Catalogue Number: 42314
• Device Lot Number: 0230391735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 03/20/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/03/2026; 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• 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
• Patient Age: 7 MO
• Patient Sex: Male
• Patient Weight: 7 KG
• Patient Race: White