MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number	FV251T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shuntassistant (#fv251t) was implanted during a procedure performed on (b)(6) 2014.According to the complainant, the shunt system was believed to be operated in overdrainage and had adjustment difficulties.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: 10 years.Height: 130 centimeters (cm).Weight: 26 kilograms (kg).Gender: male.Same event as medwatch #: 3004721439-2022-00262.
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the valve was detected during the visual inspection.Permeability test: a permeability test has shown that shuntassistant 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 valve is tested in the vertical positions.The results show that the shuntassistant operates within the accepted tolerance in vertical position.Internal inspection: after dismantling of the valve, deposits were found in shuntassistant.Results: based on our examination results, we are able to determine deposits.The deposits had no influence on the technical characteristics at the time of the examination.Existing deposits in the csf can temporarily impair the function of the valves and is described as concomitant symptoms 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.

• Brand Name: SHUNTASSISTANT 20
• 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: 15320754
• Report Number: 3004721439-2022-00264
• Device Sequence Number: 20210068
• Product Code: JXG
• UDI-Device Identifier: 04041906113209
• UDI-Public: 4041906113209
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 08/17/2022

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 Model Number: FV251T
• Device Catalogue Number: FV251T
• Device Lot Number: 20019708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2013
• 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: 10 YR
• Patient Sex: Male
• Patient Weight: 26 KG