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

Model Number	42866
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an adjustable valve.It was reported that further tests were conducted with the programmer, including the use of different equipment confirming that the programmer was functioning correctly.However, the valve was not responding to attempts to change its settings; it remained at the 1.0 setting, even after attempts to switch to other parameters and subsequently return to 0.5.Additional programming attempts were made including applying greater pressure over the valve site but resulted in no change in performance.Potential magnetic field interference was also investigated, but no such issue was identified.A ct scan showed the valve was well-positioned.Furthermore, according to the information received, the device functioned properly for approximately one year following implantation.Thus, the current issue appeared to be specific to the valve's adjustment mechanism, which was failing to respond to programming attempts.The physician raised the possibility of obtaining a replacement valve alone, without needing to replace the ventricular and peritoneal catheters.At present, provided the patient remains clinically stable, the family was somewhat reluctant to proceed with a valve replacement and was considering keeping the current device.
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 ; +1(763)526-5677
• MDR Report Key: 50484018
• Report Number: 9612501-2026-02408
• Device Sequence Number: 13289918
• Product Code: JXG
• UDI-Device Identifier: 00763000027261
• UDI-Public: (01)00763000027261(17)271024(10)0230070166
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 42866
• Device Catalogue Number: 42866
• Device Lot Number: 0230070166
• 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: 08/27/2026
• Initial Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 11/08/2024
• 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
• Patient Sex: Male