MAUDE Adverse Event Report: Christoph Miethke GmbH & Co KG SHUNTASSISTANT 2.0 (20); HYDROCEPHALUS MANAGEMENT

Model Number	FX103T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shuntassistant 2.0 (#fx103t) was implanted on (b)(6) 2024.According to the complainant, the shunt system caused an over drainage.The patient underwent a revision procedure on (b)(6) 2026.Related to medwatchno: 3004721439-2026-00276.
Event or Problem Description
It was reported that a progav 2.0 valve (#fx410t) was implanted on (b)(6) 2024.According to the complainant, the shunt system caused an overdrainage.The patient underwent a revision procedure on (b)(6) 2026.Related to medwatchno.: 3004721439-2026-00277.
Additional Manufacturer Narrative
Visual inspection during the investigation, some tissue residue on the device 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 our investigation results, we can determine organic deposits.The deposits had no effect on the technical properties at the time of the investigation.The cause of the aforementioned functional impairment is not known to us at the time of the examination.Organic matter in the cerebrospinal fluid can influence the function temporarily and are known inherent side effects in hydrocephalus therapy.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.
Additional Manufacturer Narrative
Visual inspection during the investigation, no significant deformation or damage of the valve was determined.Permeability test a permeability test has indicated that the valve has a blockage.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 the horizontal position.Because the valve is not permeable, a computer controlled test is not applicable.Adjustment test the progav 2.0 was tested and is not adjustable.Braking force and brake function test the brake functionality test has shown that the brake function is operational.However the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection after dismantling of the valve, organic deposits were found.Results based on our investigation results, we can determine a blockage of the valve.The determined organic deposits can be named as the cause for the functional deviation.Organic matter in the cerebrospinal fluid can influence the function temporarily and are known inherent side effects in hydrocephalus therapy.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 (20)
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): Christoph Miethke GmbH & Co KG; ulanenweg 2; potsdam, brandenburg 14469 ; GM 14469
• Manufacturer (Section G): Christoph Miethke GmbH & Co KG; ulanenweg 2; potsdam, brandenburg 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, brandenburg 14469 ; GM 14469
• MDR Report Key: 50913391
• Report Number: 3004721439-2026-00276
• Device Sequence Number: 14784896
• Product Code: JXG
• UDI-Device Identifier: 04041906136529
• UDI-Public: (01)04041906136529(11)240815(17)290813(10)20077133
• 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: 2024
• 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,Followup
• Report Date (Section B): 09/28/2026

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: FX103T
• Device Catalogue Number: FX103T
• Device Lot Number: 20076856
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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: 3 YR
• Patient Sex: Female
• Patient Weight: 22 LB