MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS SYSTEM WITH PED. CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX819T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a m.Blue plus (#fx819t) was implanted during a procedure performed on (b)(6) 2025.The patient was readmitted back into the hospital on (b)(6) 2025 with headache, rhinorrhea and scalp bogginess.The reprogrammed shunt after patient was readmitted and received minimal change in the patient's condition.The patient went in for a scan on (b)(6) 2025 to evaluate the shunt but they also setup an or time for (b)(6) 2025 to potentially replace the shunt system.Scans came back (b)(6) 2025 and was determined that there might be a leak around the ventricular catheter.The patient underwent a surgical procedure on (b)(6) 2025.During the surgery, no leak from the ventricular catheter and then determined, it may be coming from the periotoneal catheter but found no leak there as well.The surgeon decided to change out the entire fx819t.A new fx819t was implanted.No patient complications were reported as a result of the revision procedure.No sample for examination.The sample had already been discarded at the hospital.
Additional Manufacturer Narrative
An examination was not possible because the sample had already been discarded at the hospital.Unfortunately, due to the missing sample, we are unable to provide a meaningful analysis.Based on the production records, a defect at the time of delivery can be ruled out.The traceability shows that the shunt system was in perfect condition.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 malfunction is only possible by an examination.

• Brand Name: M.BLUE PLUS SYSTEM WITH PED. CONTROL RESERVOIR
• 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: 21746533
• Report Number: 3004721439-2025-00091
• Device Sequence Number: 3783853
• Product Code: JXG
• UDI-Device Identifier: 04041906504823
• UDI-Public: 04041906504823
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 04/01/2025

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 Expiration Date: 06/16/2025
• Device Model Number: FX819T
• Device Catalogue Number: FX819T
• Device Lot Number: 20048539
• 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: 03/12/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2020
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 91 KG