MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	FX490T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Vomiting (2144); Hydrocephalus (3272); Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the event description: patient had several ed visits in a 3-week period for episodic vomiting, somnolence, and full/tense subgaleal collection due to shunt malfunction (with enlarged ventricles).Condition imporved temporarily to shunt adjustment.Intra-op found to have very little flow through the valve.This report is filed under aic reference xc (b)(4) cc (b)(4).

• Brand Name: PROGAV 2.0®
• 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: 25048696
• Report Number: 2916714-2026-00015
• Device Sequence Number: 10410962
• Product Code: JXG
• UDI-Device Identifier: 04041906137786
• UDI-Public: (01)04041906137786(11)250515(17)300513(10)20082725
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2026
• Report Date (Section F): 04/30/2026

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: FX490T
• Device Catalogue Number: FX490T
• Device Lot Number: 20082725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/15/2026
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2026
• 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: 13 MO
• Patient Sex: Male
• Date Report Sent to FDA: 04/30/2026