• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG GAV SYSTEM W.PRECHAMBER 5/30 HYDROCEPHALUS VALVES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CHRISTOPH MIETHKE GMBH & CO. KG GAV SYSTEM W.PRECHAMBER 5/30 HYDROCEPHALUS VALVES Back to Search Results
Model Number FV328T
Device Problem Obstruction of Flow (2423)
Patient Problem Hydrocephalus (3272)
Event Date 10/24/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Implant date - (b)(6) 2014, date unknown. Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that a gav shunt valve was removed due to a malfunction. A (b)(6) patient underwent a retroauricular shunt system implantation in (b)(6) 2014. After 4 years and 7 months, it was noted that the valve was blocked. This issue led to removal of the device on (b)(6) 2018. Further details have been requested but not yet received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGAV SYSTEM W.PRECHAMBER 5/30
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 Key8126725
MDR Text Key129147631
Report Number3004721439-2018-00290
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K031303
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 12/20/2018
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 Model NumberFV328T
Device Catalogue NumberFV328T
Device Lot Number4505044768
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/05/2018
Device Age54 MO
Event Location No Information
Date Manufacturer Received12/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2013
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
-
-