MAUDE Adverse Event Report: Medtronic Dominicana Strata®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	44421
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Blurred Vision (2137)
Date of Event	09/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an adjustable valve.It was reported that the patient was diagnosed with idiopathic intracranial hypertension after failure of conservative management.Following a detailed discussion of the available treatment options with the patient and their family, the decision was made to proceed with placement of a lumboperitoneal (lp) shunt.Prior to surgery, the valve was programmed to a setting of 1.5.The procedure was performed on (b)(6) 2025, and was uneventful.Following surgery, the patient experienced gradual and significant improvement in her symptoms.Approximately one month postoperatively, however, the patient reported recurrence of her symptoms, including headaches, nausea and blurred vision.Appropriate investigations were performed to assess the position of the shunt, which demonstrated that the shunt was appropriately positioned without evidence of malposition.The valve setting was subsequently checked and was found to have changed from the original setting of 1.5 to 1.0.The valve was reprogrammed to 1.5, following which the patient's symptoms again improved.Of note, during this period, the patient had not undergone mri examination and had not knowingly been exposed to any strong magnetic field.They remained at home throughout this period and did not travel.Several months later, the patient traveled to their home country.Following their return, she again experienced recurrence of their symptoms.The valve setting was checked once more and was found to have changed from 1.5 to 0.5.The valve was again reprogrammed to 1.5.The patient was now extremely anxious and concerned regarding the repeated, unexplained changes in the valve setting.
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.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 ; +1(763)526-5677
• MDR Report Key: 50732520
• Report Number: 9612501-2026-02474
• Device Sequence Number: 13397435
• Product Code: JXG
• UDI-Device Identifier: 00763000027520
• UDI-Public: (01)00763000027520(17)300202(10)0230806601
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K091312
• 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): 09/11/2026

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: 44421
• Device Catalogue Number: 44421
• Device Lot Number: 0230806601
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 02/28/2025
• 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: 41 YR
• Patient Sex: Female