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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

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 20 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV441-T
Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative
When additional information is received a follow up report will be submitted.
 
Event Description
It was reported that there was a maladjustment of the valve.The reporter indicated that a 13 day post-operative shunt required revision surgery due to failing to control pressure.Per the reporter, when the surgeon adjusted the pressure value after the first surgery, it can't be adjusted to the desired value.Patient outcome was that the patient was able to live daily life.Normal pressure hydrocephalus (nph).
 
Manufacturer Narrative
Investigation.First, we performed a visual inspection of the progav shunt system.No significant deformations or damage of the valves were detected during the visual inspection.Next, we tested the permeability.The shunt system was shown to be permeable.Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav valve.The valve operated as expected and met all specifications.Finally, we have dismantled the progav and shunt assistant.There were no visible deposits observed inside the valves.Based on our investigation, we cannot confirm the claim of "non-adjustability".The progav is adjustable to all settings as specified.We also cannot confirm the claim of occlusion.The progav shunt system was permeable and operates within the specified tolerances.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.Detected during the visual inspection.
 
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Brand Name
PROGAV SYS PED.W/SA 20 A.PRECHAMBER
Type of Device
HYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM  14469
MDR Report Key9634814
MDR Text Key179546147
Report Number3004721439-2020-00040
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K103003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFV441-T
Device Catalogue NumberFV441-T
Device Lot Number20043870
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2019
Date Manufacturer Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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