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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYSTEM PED.WITH PRECHAMBER HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYSTEM PED.WITH PRECHAMBER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV438T
Device Problem Mechanical Problem (1384)
Patient Problems Patient Problem/Medical Problem (2688); Hydrocephalus (3272)
Event Date 05/28/2020
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided when the product is returned for investigation and has been investigated in a follow-up report.
 
Event Description
It was reported that there was a problem with a progav valve. The problem - adjustment inability of a programmable element (inability to change the shunt pressure). Patient data - (b)(6) year (age), (b)(6) kg (approx. Weight), 122 cm (approx. Height). Initial setting 5cm h20 was kept after implantation. 4 years later - symptoms of the underdrainage were gradually appearing. Valve setting could not be changed. Implantation date - (b)(6) 2015. Removal date - (b)(6) 2020. Complete miethke shunt system was implanted.
 
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Brand NamePROGAV SYSTEM PED.WITH PRECHAMBER
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 Key10239356
MDR Text Key197929947
Report Number3004721439-2020-00134
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K103003
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 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/16/2019
Device Model NumberFV438T
Device Catalogue NumberFV438T
Device Lot Number20023785
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2014
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: 07/07/2020 Patient Sequence Number: 1
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