MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS SYS W/CONTROL RESERVOIR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	FX824T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a m.Blue plus sys w/control reservoir (part # fx824t) was implanted on an unspecified date.According to the complainant, the patient's valve was not functioning properly.A revision procedure was performed on (b)(6) 2024, and the device was returned to the manufacturer for evaluation.The return kit questionnaire contained additional information.Valve over-drainage was noted prior to the revision.No housing damage was observed post-revision, but the valve adjustment was not tested.No patient complications were reported as a result of the revision procedure.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information and/or investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation results: visual inspection: during the investigation, scratches on the outer housing of the valves were 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 valves are tested in both the horizontal as well as the vertical position.The results show that the valves operate within the permissible tolerance in their respective relevant position.Adjustment test: during the adjustment test it was determined that both valves are adjustable in all pressure ranges.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 tolerances.Internal inspection: after dismantling of the valves, no deposits were found in both valves.Results: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.How the abovementioned functional impairment occurred is not clear to us at the time of examination.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/CONTROL RESERVOIR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ,; GM 14469,
• MDR Report Key: 21561497
• Report Number: 2916714-2025-00008
• Device Sequence Number: 4430461
• Product Code: JXG
• UDI-Device Identifier: 04041906504830
• UDI-Public: (01)04041906504830(11)230816(17)280810(10)20070900
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 04/02/2025
• Report Date (Section F): 03/10/2025

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: FX824T
• Device Catalogue Number: FX824T
• Device Lot Number: 20070900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/17/2025
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/02/2025
• 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 Sex: Female
• Date Report Sent to FDA: 03/10/2025