MAUDE Adverse Event Report: MEDTRONIC DOMINICANA STRATA®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42856
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding an adjustable valve.It was reported that the valve was implant on (b)(6) 2026, and then on (b)(6) 2026, the doctor stated that the valve was not working because the patient was not responding.The patient presented signs and symptoms of decompensated hydrocephalus despite having the performance changed from 2 to 1.It was noted that the patient underwent multiple ventricular punctures until this was the achieved conclusion.A revision surgery was performed on (b)(6) 2026, to see if there could be an obstruction that was impairing the functioning of the valve, and it was found that there was none.A new valve was implanted of the same model but different batch, and the patient reacted well and the valve worked perfectly.The patient's status at the time of the report was alive-no injury.
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: STRATA®
• 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: 24390161
• Report Number: 9612501-2026-00487
• Device Sequence Number: 10518925
• Product Code: JXG
• UDI-Device Identifier: 00763000027254
• UDI-Public: (01)00763000027254(17)280316(10)0231028957
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: 42856
• Device Catalogue Number: 42856
• Device Lot Number: 0231028957
• 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: 01/29/2026
• Initial Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 04/01/2025
• 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
• Patient Age: 31 MO
• Patient Sex: Male