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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX424T
Device Problem Mechanical Problem (1384)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 06/24/2020
Event Type  Injury  
Manufacturer Narrative
When additional information becomes available a follow up report will be submitted.
 
Event Description
In (b)(6) 2015, the product was used for surgery for postmeningitis hydrocephalus in a (b)(6) newborn. Pressure set inside the valve: first time : 7 cm h2o. 1 week later : 9 cm h2o. (b)(6) 2016 : 7 cm h2o. (b)(6) 2016 : 5 cm h2o. The patient was discharged because of good progress. (b)(6) 2020 : emergency hospitalization due to sudden changes in condition (headache and vomiting). Shunt failure was not seen on ct images. There was a sign of slit ventricle syndrome, so the setting pressure was changed from 5 cm h2o to 10 cm h2o. (check the changes on the computer, no x-ray). Since there was no improvement after that, a surgeon tried to change the pressure to 15cm h2o on (b)(6), but he could not change the pressure after trying to change it several times. Certas was performed on (b)(6). At last, the patient's conditions improved. After removing the valve, the surgeon tried to change the pressure, but could not confirm the change on the compass. No infection. This is the same patient from notification mdr #- 3004721439-2020-00163 and 3004721439-2020-00161.
 
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Brand NamePROGAV 2.0
Type of DeviceHYDROCEPHALUS 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 Key10404833
MDR Text Key207334994
Report Number3004721439-2020-00162
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K141687
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,Followup
Report Date 08/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/10/2020
Device Model NumberFX424T
Device Catalogue NumberFX424T
Device Lot Number20027905
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2015
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: 08/13/2020 Patient Sequence Number: 1
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