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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SHUNTASSISTANT 25 HYDROCEPHALUS VALVES

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SHUNTASSISTANT 25 HYDROCEPHALUS VALVES Back to Search Results
Model Number FX414T
Device Problem Obstruction of Flow (2423)
Patient Problems Failure of Implant (1924); Hydrocephalus (3272)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that a progav shunt valve was removed due to a malfunction. A patient underwent a retroauricular shunt system implantation in (b)(6) 2017. After a period of time, it was noted that the valve was suspected to be blocked; there was sluggish flow from the valve despite high intracranial pressure. This issue led to removal of the device in (b)(6) 2018. Further details have been requested but not yet received.
 
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Brand NamePROGAV 2.0 WITH SHUNTASSISTANT 25
Type of DeviceHYDROCEPHALUS VALVES
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8129387
MDR Text Key129204778
Report Number3004721439-2018-00297
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX414T
Device Catalogue NumberFX414T
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date11/30/2018
Event Location No Information
Date Manufacturer Received12/12/2018
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: 12/04/2018 Patient Sequence Number: 1
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