MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX428T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant a progav had a dysfunction postoperatively.The valve was implanted (b)(6) 2017.It was revised on (b)(6) 2017 and was returned to the manufacturer.Further details were not provided.Height: (b)(6).
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: ( description incoming product condition) we received the valve inserted in an unknown liquid in the provided return kit.Results: first, we performed a visual inspection of the valve.No significant deformations or damge of the valve were detected during the visual inspection.Next we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The valve was permeable with difficulty; it met all other specifications.Finally, we have dismantled the valve.There were no visible deposits observed inside.Based on our investigation, we are unable to substantiate the clinical claim of dysfunction.At the time of our investigation, the valve was fully functional and worked within specifications.Despite the lack of significant deposits, it is possible that the computer controlled test may have flushed out any existing protein deposits that may have previously contributed to a functional impairment or even non-visible or small amounts of build-up could have led to a temporary compromise of the valve and to the observed malfunction in the past.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 shunt system met all specifications of the final inspection when released from christoph miethke (b)(4).No further actions required.

• Brand Name: PROGAV 2.0 SYS W/SA25 A.SPRUNG 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: 13078773
• Report Number: 3004721439-2021-00848
• Device Sequence Number: 4278941
• Product Code: JXG
• UDI-Device Identifier: 04041906136987
• UDI-Public: 4041906136987
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2021

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: 12/31/2019
• Device Model Number: FX428T
• Device Catalogue Number: FX428T
• Device Lot Number: 20026613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2015
• 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: 74 YR
• Patient Sex: Unknown
• Patient Weight: 80 KG