MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 2.0 20; HYDROCEPHALUS MANAGEMENT

Model Number	FX102T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shunt assistant 2.0 (#fx102t) was implanted together with an progav 2.0 (#fx467t) during a procedure performed.According to the complainant, the valve was malfunctioned.The patient underwent a revision procedure on (b)(6) 2025.The complained product will be send to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.Same incident as medwatch#3004721439-2025-00161.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
An investigation was not possible because the product is not available.Due to missing information (patient data, serial number, device itself), we are unable to provide a meaningful analysis.Regarding similar complaints where we could examine the products, we could determine that the most frequent cause for a deterioration in the function of the product are deposits caused by natural substances in the cerebrospinal fluid, e.G.Protein, blood or tissue particles.These are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valve if aggregated in the valve.A final clarification of the cause what has led to the malfunction is only possible by an examination.
Event or Problem Description
No device was returned to the manufacturer same incident as medwatch#3004721439-2025-00161.

• Brand Name: SHUNTASSISTANT 2.0 20
• 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: 22411188
• Report Number: 3004721439-2025-00201
• Device Sequence Number: 9692314
• Product Code: JXG
• UDI-Device Identifier: 04041906501587
• UDI-Public: 04041906501587
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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 Model Number: FX102T
• Device Catalogue Number: FX102T
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown