• 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 SYS PED.W/SA 20 A.PRECHAMBER 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 SYS PED.W/SA 20 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV441T
Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 05/24/2017
Event Type  Injury  
Manufacturer Narrative
If additional information becomes available a follow up report will be submitted.
 
Event Description
It was reported that there was pressure adjustment failure. The reporter indicated that the product was implanted on the patients birth in (b)(6) 2015. Pressure adjustment failure was seen in (b)(6) 2017, but since no serious symptoms were observed, the doctor monitored the patients condition. However, the patients symptoms did not improve, and the device was replaced with (b)(4) in (b)(6) 2019. Patient information was not provided. Additional information has been requested.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROGAV SYS PED.W/SA 20 A.PRECHAMBER
Type of DeviceHYDROCEPHALUS MANAGEMENT
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
joerg knebel
2 ulanenweg
potsdam d, 14469
GM   14469
MDR Report Key9572036
MDR Text Key188573748
Report Number3004721439-2020-00005
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
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 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV441T
Device Catalogue NumberFV441T
Device Lot Number30100334
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
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: 01/09/2020 Patient Sequence Number: 1
-
-