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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 25 A.BURRH.RES. HYDROCEPHALUS VALVES

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 25 A.BURRH.RES. HYDROCEPHALUS VALVES Back to Search Results
Model Number FV449T
Device Problem Infusion or Flow Problem (2964)
Patient Problems Failure of Implant (1924); Hydrocephalus (3272)
Event Date 10/30/2018
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 system was explanted due to a malfunction. A (b)(6) patient underwent a shunt system implantation on (b)(6) 2018. After 16 days, it was noted that the valve adjusted on its own. This issue led to explantation of the device. Further details have been requested but not yet received.
 
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Brand NamePROGAV SYS PED.W/SA 25 A.BURRH.RES.
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 Key8126731
MDR Text Key129147613
Report Number3004721439-2018-00285
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
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 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model NumberFV449T
Device Catalogue NumberFV449T
Device Lot Number81895219
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/26/2018
Device Age44 MO
Event Location No Information
Date Manufacturer Received11/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2015
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: 12/03/2018 Patient Sequence Number: 1
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