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

Model Number	44420
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Visual Disturbances (2140); Malaise (2359)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding an adjustable shunt.It was reported that the doctor had an issue with programming the shunt that was implanted on (b)(6) 2025.The shunt was jumping from 1.5 mm h2o to 2 mm h2o.The doctor was unable to reprogram to a constant 1.5 mm h2o.The patient's condition was deteriorating as they were experiencing eye sight disturbances, nausea, feeling of unwell, and headaches.The doctor suspected the shunt was compromised or faulty.The patient was taken back to theatre to explant and replace the shunt.The doctor replaced the valve and lumbar catheter, but the peritoneal catheter remained implanted.The patient's medical history indicated an allergy to penicillin.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: 23703834
• Report Number: 9612501-2025-03225
• Device Sequence Number: 13434693
• Product Code: JXG
• UDI-Device Identifier: 00763000027537
• UDI-Public: (01)00763000027537(17)300225(10)0230929563
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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: 44420
• Device Catalogue Number: 44420
• Device Lot Number: 0230929563
• 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: 12/02/2025
• Initial Report FDA Received Date: 12/03/2025
• Date Device Manufactured: 03/23/2025
• 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: 35 YR
• Patient Sex: Female