MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SET W/SPRUNG RESERVOIR MININAV 5; HYDROCEPHALUS MANAGEMENT

Model Number	FV713T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: ( description incoming product condition) we received the valve in the return kit.Summary: first, we performed a visual inspection of the valve.A deformation of the outer housing of the valve was observed through the visual inspection.This deformation was confirmed through a measurement of the plant parallelism.The exact cause of the deformation remains unclear.Next, we tested the permeability, adjustability, aw well as the brake functionality and brake force.The valve operates as expected and met all specifications.Finally, we have dismantled the valve.Inside the valve we could not find build-up of substances.Based on our investigation results we are unable to substantiate the clinical claim of non-adjustability.At the time of our investigation the valve was adjustable to all specified pressures.We cannot explain how adjustment problems could occur in the past.We can only assume that the position of the implantation may have been chosen incorrectly due to the anatomical conditions of the patient, or the skin over the valve was too thick, which may have led to difficulties in adjusting the valve.We can exclude a defect at the time of release.The valve met all specifications of he final inspection when released from christoph miethke (b)(4).No further actions required.
Event or Problem Description
According to the complainant a prosa was difficult to reprogram postoperatively.The patient was originally implanted in (b)(6) 2016.Tlhe valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROSA SET W/SPRUNG RESERVOIR MININAV 5
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12639089
• Report Number: 3004721439-2021-00686
• Device Sequence Number: 17273791
• Product Code: JXG
• UDI-Device Identifier: 04041906133955
• UDI-Public: 4041906133955
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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: 06/30/2021
• Device Model Number: FV713T
• Device Catalogue Number: FV713T
• Device Lot Number: 20031492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 80