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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 VALVE HYDROCEPHALUS VALVES

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 VALVE HYDROCEPHALUS VALVES Back to Search Results
Model Number FX410T
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem Hydrocephalus (3272)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Explant date - (b)(6) 2018 (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 progav valve was self-adjusting. A patient underwent a retroauricular shunt system implantation on an unknown date. Sometime later postoperatively, the valve was noted to be re-setting spontaneously. This issue led to removal of the device in (b)(6) 2018. Further details have been requested but not yet received.
 
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Brand NamePROGAV 2.0 VALVE
Type of DeviceHYDROCEPHALUS VALVES
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam, 14469
GM 14469
Manufacturer (Section G)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam, 14469
GM 14469
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8187221
MDR Text Key131125482
Report Number3004721439-2018-00307
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K161853
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 05/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/11/2022
Device Model NumberFX410T
Device Catalogue NumberFX410T
Device Lot NumberN27607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/03/2019
Device Age16 MO
Event Location No Information
Date Manufacturer Received01/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2017
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: 12/20/2018 Patient Sequence Number: 1
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