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

Model Number F24363

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hydrocephalus (3272)

Event Type  malfunction  

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 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.

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 Description

The valve is still implanted.

• Brand Name: GAV SYSTEM W.PRECHAMBER 10/40
• Type of Device: 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
• MDR Text Key: 336079450
• Report Number: 3004721439-2024-00013
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K031303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention