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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS W/SA15 A.SPRUNG RESERVOIR HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS W/SA15 A.SPRUNG RESERVOIR HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX426T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/11/2020
Event Type  Injury  
Manufacturer Narrative
If additional information becomes available a follow up report will be submitted.
 
Event Description
It was reported that there is an issue with valve. The reporter indicated that a post-operative valve was not flowing properly. Per the reporter, the symptoms of the patient were going well for about a year after the surgery, but at the end of february, the patient felt a headache. Ventricle enlargement was confirmed and the surgeon tried to lower the pressure of the product; however, it did not work properly. Then, the contrast agent inspection was carried out and it was found that the valve was not blocked completely but the flow was not well. The device was explanted. Additional event details and patient information have been requested.
 
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Brand NamePROGAV 2.0 SYS W/SA15 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 Key9913211
MDR Text Key188554534
Report Number3004721439-2020-00075
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,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX426T
Device Catalogue NumberFX426T
Device Lot Number20039186
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 Received04/09/2020
Was Device Evaluated by Manufacturer? Yes
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: 04/01/2020 Patient Sequence Number: 1
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