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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYSTEM W/CONTROL RESERVOIR HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYSTEM W/CONTROL RESERVOIR HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV431T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/29/2019
Event Type  Injury  
Manufacturer Narrative
When additional information is received a follow up report will be submitted.
 
Event Description
It was reported that unable to adjust setting. The reporter indicated that a 5 month 19 day post-operative shunt was unable to be adjusted and required explantation. Per the reporter, the proximal end had some blockage. Additional event details and patient information was not provided.
 
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Brand NamePROGAV SYSTEM W/CONTROL 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 Key9634524
MDR Text Key188558974
Report Number3004721439-2020-00041
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeSN
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 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2022
Device Model NumberFV431T
Device Catalogue NumberFV431T
Device Lot NumberWS-00136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2016
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: 01/27/2020 Patient Sequence Number: 1
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