MAUDE Adverse Event Report: CHRISTOP MIETHKE GMBH & CO KG MININAV SET PED.5 W/PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV679T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No significant deformations or damage of the valve were detected during the visual inspection.A permeability test has shown that the valve is permeable.To investigate the claim of under-drainage, the fixed pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.The results show that the valve not operates within the accepted tolerance in both positions.After dismantling of the valve, deposits were found inside.Based on our investigation, we confirm that the valve shows a slower flow of liquid at the time of our investigation.This is likely due to the deposits observed inside the valve.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a mininav (part # fv679t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the valve was believed to be operated in under-drainage.The patient underwent a revision procedure performed on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 2 months.Height: 48 centimeters (cm).Weight: 3.8 kilograms (kg).Gender: male.

• Brand Name: MININAV SET PED.5 W/PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOP 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: 16219059
• Report Number: 3004721439-2022-00423
• Device Sequence Number: 7435208
• Product Code: JXG
• UDI-Device Identifier: 04041906133276
• UDI-Public: 4041906133276
• Combination Product (Y/N): N
• Initial Reporter Country: RW
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2023

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: FV679T
• Device Catalogue Number: FV679T
• Device Lot Number: 20059092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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 Age: 2 MO
• Patient Sex: Male
• Patient Weight: 4 KG