MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG CONTROLRESERVOIR SET W/DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FV049T
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: the product in question was not returned to the manufacturer as it is still implanted.
Event or Problem Description
It was reported that a control reservoir set with distal.Catheter (#fv049t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the system caused a malfunction.The patient underwent another surgery, but the system was not removed because the catheter had grown into the tissue.However, a new system was additionally implanted.No patient complications were reported as a result of the surgery procedure.The complained product was not sent to the manufacturer because it is still implanted.Same event as # 3004721439-2025-00206.

• Brand Name: CONTROLRESERVOIR SET W/DISTAL CATHETER
• 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: 22554263
• Report Number: 3004721439-2025-00205
• Device Sequence Number: 15864944
• Product Code: JXG
• UDI-Device Identifier: 04041906131487
• UDI-Public: 4041906131487
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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: FV049T
• Device Catalogue Number: FV049T
• Device Lot Number: 20073125
• 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: 06/25/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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 Sex: Unknown