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

Model Number	9040 E
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	01/14/2026
Type of Reportable Event	Death
Event or Problem Description
Medtronic received information regarding a non-adjustable shunt/valve.It was reported that post-operatively, the patient was noted to have decreased consciousness with an impression of inadequate shunt/pump function.Following a head ct scan evaluation, ventricular enlargement was observed.The ventricular catheter was noted to be in a good position.It was unknown if an intervention was performed, however, a procedure was completed with back up products.The patient's status at the time of the report was deceased.The patient's medical history was obstructive hydrocephalus and space-occupying lesion (sol) of the intracranial cerebellum.Additional information received reported that there was no testing performed on each component to determine if the shunt was occluded.The timeline between shunt implantation and onset of decreased consciousness/death was 29 days.The patient's neurological assessments before the initial procedure was gcs score of e4m6v5.No autopsy was performed.The shunt was tested intra-operatively for patency.
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 SHUNT
• 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: 25553896
• Report Number: 9612501-2026-01666
• Device Sequence Number: 10731681
• Product Code: JXG
• UDI-Device Identifier: 00763000027872
• UDI-Public: (01)00763000027872(17)300410(10)0231230908
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K831678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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: 9040 E
• Device Catalogue Number: 9040 E
• Device Lot Number: 0231230908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 05/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG