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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPHER METHKE GMBH & CO. KG PROGAV VALVE HYDROCEPHALUS VALVES

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CHRISTOPHER METHKE GMBH & CO. KG PROGAV VALVE HYDROCEPHALUS VALVES Back to Search Results
Model Number FX410T
Device Problem Obstruction of Flow (2423)
Patient Problem Failure of Implant (1924)
Event Date 11/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Implant date: (b)(6) 2008 (day unknown). When additional information is received a follow up report will be submitted.
 
Event Description
It was reported by the healthcare professional "10y 7m po overdrainage of the valve. Explanted. ".
 
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Brand NamePROGAV VALVE
Type of DeviceHYDROCEPHALUS VALVES
Manufacturer (Section D)
CHRISTOPHER METHKE 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 Key8157938
MDR Text Key130165066
Report Number3004721439-2018-00295
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2012
Device Model NumberFX410T
Device Catalogue NumberFX410T
Device Lot Number4501070419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/11/2018
Device Age11 YR
Event Location No Information
Date Manufacturer Received12/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2007
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: 12/12/2018 Patient Sequence Number: 1
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