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

Model Number	42866
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Intracranial Hemorrhage (1891); Pain (1994)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding an adjustable shunt.It was reported that the patient had a brain bleed (b)(6) 2025 shortly after the placement ((b)(6) 2025) of a shunt and had to have the shunt revised.The surgeon allegedly removed the shunt, cleaned it out, and then re-implanted it.The patient now experienced seizure clusters where they strike the side of the their skull where the shunt was placed.Additional information received clarified that the patient had valve pain where they would start pummeling the valve which occurred within the context of their seizure cluster events, not always but most often and at the very beginning of the event.Then, the patient would try to dash across the house (usually used a wheelchair as they had an unstable gait).If not at home, tried to bolt.This was not their typical behavior at baseline: left arm, left leg, left foot rhythmic shaking, staring, head dropping, loss of tone - fell out of wheelchair, eyes to right, head to right <(>&<)> up towards the seizures.The seizures were generally focal seizures until recently.The patient had a history of tonic clonic seizures since birth though.They were diagnosed with frontal lobe epilepsy in 2023 and had a history of slit ventricles dating back to 2016.There were allegations that the nurses had a habit of withholding (or giving late) the patient¿s antiseizure and antiepileptic medication leading to the patient having seizures.There were additional allegations regarding the doctor not remembering the patient, and it caused an enormous quagmire after the patient's sodium dropped dangerously low because the doctor adjusted the patient's oxcarb without addressing/ adjusting their buffered salt tabs and the emergency nurses gave the patient a copious amount of fluids one night in the emergency room ((b)(6) 2025) causing the patient to be hospitalized.This was the second time an error had occurred at the hospital regarding the patient's sodium.In (b)(6) 2025, the patient had several small subdural hematomas.The patient was screaming worst headache of their life labor day weekend 2025.The following friday, the doctor adjusted the valve from 1.5 to 2 and then again from 2.0 to 2.5 on (b)(6) 2025.
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
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: 23960333
• Report Number: 9612501-2026-00018
• Device Sequence Number: 9528060
• Product Code: JXG
• UDI-Device Identifier: 00763000027261
• UDI-Public: (01)00763000027261(17)271112(10)0230181923
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: 0230181923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 11/27/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: American Indian Or Alaskan Native