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

Model Number	FX819T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Headache (1880)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a m.Blue plus sys w/ped.Control reservoir (part# fx819t) was implanted on (b)(6)2025.According to the complaint description the patient was fine and then was readmitted back into the hospital on (b)(6) 2025 with headache, rhinorrhea and scalp bogginess.The physician 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 was revised on (b)(6) 2025.During the surgery, they found no leak from the ventricular catheter and then determined, it may be coming from the peritoneal catheter, but found no leak there as well.The surgeon decided to change out the entire fx819t.They explanted the original fx819t and the was patient implanted with new fx819t with settings of 6 and 20 again.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.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: M.BLUE PLUS SYS W/PED.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: 21746530
• Report Number: 2916714-2025-00012
• Device Sequence Number: 3783852
• Product Code: JXG
• UDI-Device Identifier: 04041906504823
• UDI-Public: (01)04041906504823(11)200626(17)250616(10)20048539
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 04/01/2025
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/12/2025
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2025
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Date Report Sent to FDA: 04/01/2025