MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W.SA15 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX433T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the device is not applicable as the valve is still implanted.Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 (part # fx433t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, after a preventive check-up using magnetic resonance imaging (mri), a pressure setting adjustment was believed as being needed due to a different pressure setting than required.The adjustment did not work.However, the patient was fine and has no symptoms, so a revision was not needed.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Examination of the device is not applicable as the valve is still implanted.The patient's health is not affected in any way.A medical device advisors could help and reviewed this case with the surgeon and the pressure setting could be changed.

• Brand Name: PROGAV 2.0 SYS W.SA15 A.CONTROL RESERV.
• 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: 13509852
• Report Number: 3004721439-2022-00018
• Device Sequence Number: 4073778
• Product Code: JXG
• UDI-Device Identifier: 04041906137311
• UDI-Public: 4041906137311
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2025
• Device Model Number: FX433T
• Device Catalogue Number: FX433T
• Device Lot Number: 20047515
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2020
• 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
• Patient Sex: Male