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

Model Number	42856
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Headache (1880); Nerve Damage (1979); Optical Nerve Damage (1986); Loss of Vision (2139); Vomiting (2144); Convulsion/Seizure (4406)
Date of Event	03/27/2018
Type of Reportable Event	Serious 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.
Event or Problem Description
Medtronic received information regarding an adjustable shunt.It was reported that on (b)(6) 2011, the patient underwent lateral ventricle-abdominal cavity shunt implantation for hydrocephalus under general anesthesia, with a brain-thoracoabdominal shunt system and components.The implantation procedure was smooth, the process followed standard protocols, and no adverse reactions occurred.The patient was followed up for six years until the end of 2017, when recurrent headaches developed and progressively worsened.In (b)(6) 2018, the symptoms escalated to severe headache, vomiting, and convulsions, leading to readmission.The pressure setting of the hydrocephalus shunt device was adjusted.On (b)(6) 2018, the patient decided to transfer to another hospital, where doctor in (b)(6) discovered drainage tube malfunction and replaced the drainage tube.This resulted in optic nerve atrophy and complete loss of vision, and the patient was diagnosed with first-degree visual impairment.It was noted that the surgery took place more than 15 years ago, and the patient had not visited the hospital since.Since the specific replacement surgery was performed at another hospital, the exact product used for the replacement was unknown.
Additional Manufacturer Narrative
H6.Additional annex e codes added.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.
Event or Problem Description
Additional information received reported that the patient's underlying diagnosis was hydrocephalus.The patient did not have any other medical conditions.There was no relief in symptoms after the valve pressure adjustment in (b)(6) 2018.No imaging studies were performed to confirm the catheter malfunction.Imaging or interrogation of the shunt valve did not reveal any signs of increased intracranial pressure or hydrocephalus before the catheter issue was discovered.The optic nerve atrophy and vision loss might be attributed to the increased intracranial pressure.
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 NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: justin ellis ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 24055705
• Report Number: 2021898-2026-00001
• Device Sequence Number: 9855981
• Product Code: JXG
• UDI-Device Identifier: 00613994804631
• UDI-Public: (01)00613994804631(17)140228(10)D00546
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042465
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2026

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 Expiration Date: 02/28/2014
• Device Model Number: 42856
• Device Catalogue Number: 42856
• Device Lot Number: D00546
• 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: 01/04/2026
• Supplement Date Received by Manufacturer: 03/05/2026; 03/06/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/06/2026; 03/06/2026
• Date Device Manufactured: 04/11/2011
• 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: 11 YR
• Patient Sex: Female