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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYSTEM W/SA 10 A.SPRUNG RESERVOIR HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYSTEM W/SA 10 A.SPRUNG RESERVOIR HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV425T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/20/2019
Event Type  Injury  
Manufacturer Narrative
Height: 170cm. When additional information becomes available a follow up report will be submitted.
 
Event Description
The reporter indicated that a 3 year 2 month post-operative valve cannot be adjusted. Per the reporter, according to the physician the patient's shunt insertion in 2016. The patient's general condition was stable under the initial pressure setting control; the adjustable pressure was 10. However, two weeks ago, the physician ordered to change the adjustable pressure from 10 to 5. It was then noticed that the valve couldn't be adjusted. The physician also reviewed the skull x-ray, which revealed the pressure of the valve, remained at 10. As a result, shunt explantation was done.
 
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Brand NamePROGAV SYSTEM W/SA 10 A.SPRUNG RESERVOIR
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 Key9639642
MDR Text Key188549279
Report Number3004721439-2020-00031
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K103003
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,Followup
Report Date 02/10/2020
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 Date12/31/2020
Device Model NumberFV425T
Device Catalogue NumberFV425T
Device Lot Number20031334
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 Received01/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/12/2016
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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