MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV047T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a control reservoir (part # fv047t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the control reservoir was believed to be blocked.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: 8 years.Height: 125 centimeters (cm).Weight: 28 kilograms (kg).Gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: deposits in the control reservoir.Permeability test: a permeability test has indicated that the control reservoir is not permeable.Internal inspection: after dismantling the valve spout, deposits were found in the valve spout.Results: for the sake of thoroughness and transparency, we would like to point out that a permeability test was already carried out after the revision at the hospital.Based on our investigation, we confirm the presence of occlusion in the control reservoir at the time of investigation.This is likely due to the deposits observed inside the valves.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 reservoir met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required from our point of view.

• Brand Name: CONTROL RESERVOIR
• 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: 15245483
• Report Number: 3004721439-2022-00237
• Device Sequence Number: 15041793
• Product Code: JXG
• UDI-Device Identifier: 04041906131463
• UDI-Public: 4041906131463
• 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: 2020
• 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: FV047T
• Device Catalogue Number: FV047T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 8 YR
• Patient Sex: Female
• Patient Weight: 28 KG