MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 2.0 (25); HYDROCEPHALUS MANAGEMENT

Model Number	FX103T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shuntassistant 2.0 (#fx103t) was implanted on (b)(6) 2021.According to the complainant, the valve caused an over-drainage.The patient underwent a revision procedure on (b)(6) 2026.No patient complications were reported as a result of the revision procedure.Related to rm 5995 - cc400760246 | med.Watchno.: 3004721439-2026-00152.
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 all components are permeable.Computer controlled test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in vertical/ or both the horizontal as well as the vertical positions.The results show that the shuntassistant 2.0 operates within the accepted tolerance in both positions.Internal inspection: after dismantling of the valve, organic deposits were found.Results: based on the results of the investigation, visible deposits were detected in the shuntassistant 2.0.These deposits did not affect the device's technical performance at the time of the investigation.At the time of the examination, it was not clear to us how the aforementioned functional impairment occurred.Organic material in the patient's own cerebrospinal fluid may have temporarily affected function and is a known side effect of hydrocephalus therapy.Not every deposit in a shunt system[?]depending on its location, quantity, and consistency[?]leads to a deterioration in performance.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 2.0 (25)
• 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: 25430535
• Report Number: 3004721439-2026-00153
• Device Sequence Number: 10335498
• Product Code: JXG
• UDI-Device Identifier: 04041906501594
• UDI-Public: 4041906501594
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/08/2026

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: 05/09/2026
• Device Model Number: FX103T
• Device Catalogue Number: FX103T
• Device Lot Number: 20053445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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: 16 YR
• Patient Sex: Male
• Patient Weight: 60 KG