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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG GAV SYSTEM W/SPRUNG RESERVOIR 5/35 HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG GAV SYSTEM W/SPRUNG RESERVOIR 5/35 HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV347T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/05/2019
Event Type  Injury  
Manufacturer Narrative
Height: 183cm. Investigation. Visual inspection: no significant deformations or damage of the valve were 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 dysfunction, the opening pressure is measured using a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow. The valve is tested in both the horizontal as well as the vertical positions. The results show that the valve operates within the accepted tolerance in both positions. Results: first, we performed a visual inspection of the gav. 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 both positions. Finally, we have dismantled the valve. Inside the valve, we have found a build-up of substances (likely protein). Based on our investigation, we are unable to substantiate the claim of dysfunction. At the time of our investigation, the valve was operating within the specified tolerances. However, it is possible that the deposits observed inside the valve could have caused the 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 valve met all specifications of the final inspection when released from christoph miethke (b)(4).
 
Event Description
The reporter indicated that an 11 year 6 month post-operative shunt dysfunctioned. The device was explanted. Additional information regarding event details have not been provided.
 
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Brand NameGAV SYSTEM W/SPRUNG RESERVOIR 5/35
Type of DeviceHYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
Manufacturer (Section G)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
Manufacturer Contact
joerg knebel
2 ulanenweg
potsdam d, 14469
GM   14469
MDR Report Key9639409
MDR Text Key187017870
Report Number3004721439-2020-00030
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K031303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2011
Device Model NumberFV347T
Device Catalogue NumberFV347T
Device Lot Number4500764830
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/28/2020 Patient Sequence Number: 1
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