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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX441T
Device Problem Infusion or Flow Problem (2964)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/14/2020
Event Type  Injury  
Manufacturer Narrative
An investigation was not possible, because the product was not send in because covid-19. The shunt system was inspected as article fx441t. All parameters are inspected and signed during the manufacturing process. All parameters have been assessed as meeting specifications. Result: as described in our instructions for use, in the treatment of hydrocephalus with shunts, the following complications may arise (as described in scientific literature): infections, blockages caused by protein and/or blood in the cerebrospinal fluid or over-/ and under-drainage. Due to violent shocks from the outside (accident, fall, etc. ) the integrity of the shunt may be endangered. However, we cannot finally clarify what influenced the product condition, as this would require an examination of the shunt system. Based on our documentation however we can exclude a defect at the time of release. The progav® 2. 0 shunt system met all specifications of the final inspection when released from christoph miethke (b)(4). No further regulatory actions are required from our point of view.
 
Event Description
It was reported that there was a problem with a progav 2. 0 shunt system. The first surgery was performed on (b)(6) 2018, but as the ventricles expanded and the symptoms worsened. The pressure setting was also lowered but ventricular contraction was not seen. Therefore there was a high possibility of shunt dysfunction and clogging. The surgeon decided to perform a revision surgery on (b)(6) 2020. The surgeon tried pumping several times, but no improvement. The removed valve was not blocked. Further informations are not available. The product was not send in for investigation because covid-19.
 
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Brand NamePROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER
Type of DeviceHYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO KG
ulanenweg 2
potsdam, 14469
GM 14469
Manufacturer (Section G)
CHRISTOPH MIETHKE GMBH & CO KG
ulanenweg 2
potsdam, 14469
GM 14469
Manufacturer Contact
joerg knebel
ulanenweg 2
potsdam, 14469
GM   14469
MDR Report Key10393134
MDR Text Key202533573
Report Number3004721439-2020-00156
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX441T
Device Catalogue NumberFX441T
Device Lot Number20037867
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2018
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: 08/11/2020 Patient Sequence Number: 1
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