MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 2.0 25; HYDROCEPHALUS MANAGEMENT

Model Number	FX649T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of over/ under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The results show that the valve operates within the accepted tolerance in both positions.Internal inspection : after dismantling of the valve, deposits were found in shuntassistant 2.0.Results: based on our investigation results, we can determine deposits.The deposits had no effect to the technical properties at the time of the investigation.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.We can exclude a defect at the time of release.The shunt system 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 shuntassistant 2.0 (part of shuntsystem #fx649t) was implanted during a procedure performed on an unknown date.According to the complainant, the patient underwent a revision procedure on november (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: 5 years, height: 100 centimeters (cm), weight: 15 kilograms (kg), gender: female.Same event/patient as medwatch # 3004721439-2022-00367.

• Brand Name: SHUNTASSISTANT 2.0 25
• 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: 15936725
• Report Number: 3004721439-2022-00368
• Device Sequence Number: 17729090
• Product Code: JXG
• UDI-Device Identifier: 04041906502072
• UDI-Public: 4041906502072
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2022

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 Expiration Date: 09/18/2024
• Device Model Number: FX649T
• Device Catalogue Number: FX649T
• Device Lot Number: 20043851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2019
• 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: 5 YR
• Patient Sex: Female
• Patient Weight: 15 KG