MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS SYS W/SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT,

Model Number	FX834T
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
According to the complainant the shunt was explanted because cerebrospinal fluid (csf) was accumulating.Additional information has been requested but not yet provided.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Additional information: a2 patient age.A3a gender.B7 relevant history.D item information updated.D6a, d6b implant and explant date.D9 device returned to manufacturer date.Visual inspection: during the investigation, no significant deformations or damages of the valves were determined.Permeability test: a permeability test has shown that both valves are permeable.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical position.The result shows that the m.Blue operates not within the accepted tolerances in the horizontal position.However, the progav 2.0 operates within the specified tolerances.An slower outflow of m.Blue could be determined.Adjustment test: the valves were tested and both valves are adjustable in all pressure settings.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected and the braking force is within the given tolerance.Internal inspection: after dismantling of the valves, organic deposits were found in both valves.Results: according to the results of the investigation, a reduced outflow of the m.Blue in the horizontal position was detected.The visible deposits led to the functional deviation.Furthermore, visible deposits in the progav 2.0 were determined.The deposits had no effect upon the specifications at the time of the examination.The valve operated within all specifications.Deposits caused by substances naturally present in the patient's body, such as protein, blood or tissue particles, 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.The examination of the return has been completed with the drafting of this report.We can exclude a defect at the time of release.The shunt system 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: M.BLUE PLUS SYS W/SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT,
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ,; GM 14469,
• MDR Report Key: 23496104
• Report Number: 2916714-2025-00072
• Device Sequence Number: 18420835
• Product Code: JXG
• UDI-Device Identifier: 04041906504854
• UDI-Public: (01)04041906504854(11)240531(17)290521(10)20075598
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025
• Report Date (Section F): 11/07/2025

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: FX834T
• Device Catalogue Number: FX834T
• Device Lot Number: 20075598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/20/2025
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 MO
• Patient Sex: Male
• Date Report Sent to FDA: 11/07/2025