• 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 PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

  • 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 PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX434T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/14/2020
Event Type  Injury  
Manufacturer Narrative
Height: 82 cm.Date of implant: day unknown.When additional information becomes available a follow up report will be submitted.
 
Event Description
It was reported that a valve has a blockage.The reporter indicated that a 1 year 8 month post-operative valve had a blockage and required explantation.Additional event details were not provided,.
 
Manufacturer Narrative
A visual inspection of the progav 2.0 shunt system was performed.No significant deformations or damage of the valves were detected during the visual inspection.Next, the permeability was tested.Both valves were shown to be permeable.Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav 2.0 valve.The valve was not adjustable to all settings.The brake functionality was fully operational, however due to the inability of the valve to change a pressure setting, it was not possible to measure the brake force.Inside the progav 2.0 we have found significantly build-up of substances (likely protein).Based on our investigation, we confirm that the progav 2.0 valve was non-adjustable at the time of our investigation.This is likely due to the deposits observed inside the valve.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.
Type of Device
HYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM  14469
MDR Report Key9612302
MDR Text Key175736952
Report Number3004721439-2020-00025
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K141687
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/11/2022
Device Model NumberFX434T
Device Catalogue NumberFX434T
Device Lot Number20035365
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2020
Date Manufacturer Received01/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age24 MO
Patient Weight10
-
-