• 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 SHUNTSYSTEM 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 SHUNTSYSTEM HYDROCEPHALUS MANAGEMENT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis. Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event. The device history records (dhr) were not able to be reviewed as the lot number was not made available. However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Event Description
It was reported that a progav 2. 0 shuntsystem (part # unknown) was implanted during a procedure performed on an unknown date. According to the complainant, the shunt system experienced an unspecified malfunction. The patient underwent a revision procedure on an unknown date. The complaint device was not available to be returned to the manufacturer for evaluation. No patient complications were reported as a result of the revision procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROGAV 2.0 SHUNTSYSTEM
Type of DeviceHYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO KG
ulanenweg 2
potsdam, 14469
GM 14469
MDR Report Key13721658
MDR Text Key286941293
Report Number2916714-2022-00018
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/10/2022
Distributor Facility Aware Date02/18/2022
Event Location Hospital
Date Report to Manufacturer02/18/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/10/2022 Patient Sequence Number: 1
-
-