MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 15; HYDROCEPHALUS MANAGEMENT

Model Number	FV250T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an shuntassistant 15 (#fv250t) was implanted to reduce the size of the ventricle.According to the hospital, it seemed like the shuntassistant was working too well.Therefore, an additional surgery was performed to switch the shuntassistant with a pressure setting of 10.
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to determine the opening pressure, the valve is measured using a computer-controlled testing device from miethke that simulates the flow of cerebrospinal fluid.The valves are tested in both horizontal and vertical positions.The results show that the shuntassistant operates within the accepted tolerance in both positions.Internal inspection: after dismantling of the valve, no deposits were found inside.Results: based on our investigation results, we cannot determine any functional deviations or other abnormalities in the product.The product operated within all specifications.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: SHUNTASSISTANT 15
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 25001840
• Report Number: 3004721439-2026-00111
• Device Sequence Number: 18325246
• Product Code: JXG
• UDI-Device Identifier: 04041906113100
• UDI-Public: (01)04041906113100(11)251121(17)301120(10)20086715
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: FV250T
• Device Catalogue Number: FV250T
• Device Lot Number: 20086715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2025
• 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: 59 YR
• Patient Sex: Female