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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA VALVE HYDRCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROSA VALVE HYDRCEPHALUS MANAGEMENT Back to Search Results
Model Number FV701T
Device Problem Mechanical Problem (1384)
Patient Problems Patient Problem/Medical Problem (2688); Hydrocephalus (3272)
Event Date 06/08/2020
Event Type  Injury  
Manufacturer Narrative
Exact height: 4´8 feet. Exact weight: 81 pounds. Investigation is completed. Visual inspection: we have checked for possible damages, deformations of the housing or other abnormalities. - no abnormalities are observed. Measurement of surface of the housing: to verify whether the deformation had an effect on the plane-parallelism of the housing surface, this was measured using a dial gauge. The measurement of the plane parallelism confirmed the non- deformation of the visual inspection. The measured value of -0. 002 mm lies within the given tolerance [0 ± 0. 02mm]. Permeability test: this test is carried out with the product in the horizontal position with a hydrostatic pressure difference of approx. 30 cmh2o in the direction of flow. The test showed that the prosa is permeable. Adjustability test: we have investigated whether the prosa can be successfully set to each specified pressure setting. The prosa was found to be adjustable to all pressure settings. Braking force and brake function test: a specific measurement device apparatus of braking force is used to investigate the braking force and the brake function of adjustable valves. His apparatus tests whether the braking function is present and how much force must be exerted on the housing to release the rotor to adjust the valve using the integrated magnet of the braking force apparatus. The braking force of the prosa was within the specified tolerance and the brake function operated as expected. After dismantling of the valve, slightly deposits were found in prosa. Based on our investigation, we are not able to substantiate the claim of "programming issues. " at the time of the investigation, it is not clear to us how the mentioned functional impairment occurred. Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy. Even small amounts of non- visible deposits might compromise the integrity of the valve. 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 (b)(4). From our point of view, no further regualatory actions are required.
 
Event Description
It was reported that the was an issue with a prosa and progav 2. 0. "the surgeon attempted to move the prosa setting from 12 to 14. When she adjusted valve to 0. Attempted to move back to 12- 14 and valve was stuck at 0. She also believes there have been inconstant readings on progav 2. 0. " height: 4´8 feet. Implantation: 2018. Removal: (b)(6) 2020. "associated medwatches: 3004721439-2020-00110 , mdr # - same patient. ".
 
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Brand NamePROSA VALVE
Type of DeviceHYDRCEPHALUS 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 Key10205892
MDR Text Key196820456
Report Number3004721439-2020-00123
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/07/2019
Device Model NumberFV701T
Device Catalogue NumberFV701T
Device Lot Number20022636
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2014
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: 06/29/2020 Patient Sequence Number: 1
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