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

Model Number FV251T

Device Problem Infusion or Flow Problem (2964)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

Height: 81 cm.When additional information becomes available a follow up report will be submitted.

Event Description

It was reported that the valve was over draining.The reporter indicated that a 1 year 4 month post operative valve is over draining.Additional details of the event have not been provided.

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 the valve is permeable.Adjustment test this is a fixed pressure valve.An adjustment test is not applicable.Braking force and brake function test this is a fixed pressure valve.A braking force and brake function test is not applicable.Computer controlled test to investigate the claim of over-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 position.The results show that the valve is operating within the accepted tolerance in the vertical position.Results first, we performed a visual inspection of the shunt assistant.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability of the valve.The valve was shown to be permeable.Then we carried out a computer controlled simulated flow test.The measured opening pressure was within the accepted tolerance in the vertical positions.Finally, we have dismantled the valve.Inside the valve we have found slightly build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of over-drainage.At the time of our investigation, the valve was operating within the specified tolerances.The observed deposits in the valve could have been a cause of the valve's temporary malfunction.As described in the 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 valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: SHUNTASSISTANT 20
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8962882
• MDR Text Key: 156904541
• Report Number: 3004721439-2019-00218
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K110206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: FV251T
• Device Catalogue Number: FV251T
• Device Lot Number: 20036148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 09/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 MO
• Patient Weight: 11