MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV SYSTEM W.PRECHAMBER 10/40; HYDROCEPHALUS MANAGEMENT

Model Number	F24363
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Event or Problem Description
It was reported that a progav system (#fv332t) was implanted during a procedure performed 2015.According to the complainant, the valve showed problems, the patient does not feel well.The shuntssystem ist still implanted.Gender: male.
Additional Manufacturer Narrative
Due to the still implanted product, the investigation is restricted to traceability of manufacturing and quality control data.An investigation was not possible, because the product is still implanted.Based on the product documentation, it can be excluded a defect at the time of delivery of the gav.The traceability indicates that the valve was in perfect condition.It is not possible to clarify the cause of the fall.
Event or Problem Description
The valve is still implanted.

• Brand Name: GAV SYSTEM W.PRECHAMBER 10/40
• 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: 18657888
• Report Number: 3004721439-2024-00013
• Device Sequence Number: 6885292
• Product Code: JXG
• UDI-Device Identifier: 04041906127206
• UDI-Public: 4041906127206
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K031303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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: 03/10/2019
• Device Model Number: F24363
• Device Catalogue Number: F24363
• Device Lot Number: 20022594
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2014
• 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