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

Model Number	44421
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
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) 2025, under general anesthesia, the patient underwent lumbar cistern-abdominal shunt surgery.Postoperatively, the shunt valve pressure was adjusted multiple times (on (b)(6) 2025, to setting 2.0, on (b)(6) 2025, to setting 1.5, and on (b)(6) 2025, to setting 1.0).On (b)(6) 2025, due to right chronic suppurative otitis media with cholesteatoma, the patient underwent right open modified radical mastoidectomy, and postoperative recovery was good.On (b)(6) 2025, physical examination revealed subcutaneous fluid accumulation at the shunt reservoir in the right hip.An urgent superficial color doppler ultrasound showed an anechoic fluid area surrounding the shunt tube.On (b)(6) 2025, approximately 10 ml of fluid (light red, odorless) was aspirated by puncture, and the shunt valve pressure was further adjusted to setting 1.0.On (b)(6) 2025, physical examination showed that the sensation of fluid accumulation was reduced compared to before, with no redness or tenderness.To evaluate shunt function, an urgent upright abdominal x-ray was performed, which indicated "discontinuity at the shunt valve interface," confirming shunt tube interface fracture.Immediate re-examination revealed that the patient was alert, with stable vital signs (t 36.5°c, p 75 bpm, r 20 bpm, bp 121/65 mmhg), and no symptoms of hydrocephalus recurrence such as headache, nausea, vomiting, or worsening limb weakness.There was no abnormal exudation at the right ear surgical site.Limb muscle strength was unchanged (right upper limb: grade 5, right lower limb: grade 3-, left upper limb: grade 4, left lower limb: grade 3).The patient had a history of cranial radiotherapy and radiation-induced brain injury, requiring long-term bedridden status and limb rehabilitation training after surgery.Frequent and extensive limb movements may have continuously exerted traction force on the shunt tube interface.Subcutaneous fluid accumulation occurred in the right hip shunt tube area; although there was no evidence of infection, the effusion may have caused local tissue edema, indirectly affecting the stability of the shunt tube interface.
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: 23025512
• Report Number: 9612501-2025-02408
• Device Sequence Number: 9514581
• Product Code: JXG
• UDI-Device Identifier: 00763000027520
• UDI-Public: (01)00763000027520(17)281018(10)0227758819
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 0227758819
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 09/18/2025
• Date Device Manufactured: 11/14/2023
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 90 KG