MAUDE Adverse Event Report: Christoph Miethke GmbH & Co KG PROGAV 2.0; Shunt, central nervous system and components

Model Number	FX654T
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 with sa2.0 20 & prechamber (part number: fx654t) was implanted in a patient on an unspecified date in 2023.Reportedly during a clinical visit, the valve was unable to be reprogrammed.The device was explanted and replaced with an mblue 10 valve.Additional information has been requested but not yet provided.This report is filed under aic reference (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: 50235963
• Report Number: 50235963
• Device Sequence Number: 18733184
• Product Code: JXG
• UDI-Device Identifier: 04041906503284
• UDI-Public: (01)04041906503284(11)221223(17)271222(10)20062912
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2026
• Report Date (Section F): 08/13/2026

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: FX654T
• Device Catalogue Number: FX654T
• Device Lot Number: 20062912
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/21/2026
• Device Age: 43 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2026
• 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 Sex: Unknown
• Date Report Sent to FDA: 08/13/2026