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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 20 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 20 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV441T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/14/2020
Event Type  Injury  
Manufacturer Narrative
If additional information becomes available a follow up report will be submitted.
 
Event Description
It was reported that a valve could not be adjusted. The reporter indicated that the pressure of the product could not be adjusted, check inside the valve and if the release pressure was working properly. This product had been implanted since (b)(6) 2008. From 2016, the pressure seemed to be unable to be adjusted but there was no blockage and cerebrospinal fluid was flowing. Therefore, the doctor was monitoring the symptom. Recently in 2020, the patient stated she had headache, so the doctor did revision of the product due to dysfunction caused by come off of the peritoneal catheter.
 
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Brand NamePROGAV SYS PED.W/SA 20 A.PRECHAMBER
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 Key9668058
MDR Text Key186105924
Report Number3004721439-2020-00039
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 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/10/2013
Device Model NumberFV441T
Device Catalogue NumberFV441T
Device Lot Number20007802
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 Received02/04/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/11/2008
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: 02/04/2020 Patient Sequence Number: 1
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