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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 W/SA20 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT
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CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX434-T
Device Problem Decrease in Pressure (1490)
Patient Problem Hydrocephalus (3272)
Event Date 07/05/2020
Event Type  Injury  
Manufacturer Narrative
Additional information / investigation results will be provided in a supplemental report, if available.
 
Event Description
It was reported that there was a problem with a progav 2.0 shunt system.Patients were implanted with the product around the beginning of (b)(6) 2020.About two weeks after the operation, it was found that the shunt effect was very poor.The pressure was continuously lowered, but the ventricles were still too large.After the replacement of a new product, the patient's condition was significantly improved.Patient information: age: unknown.Weight: unknown.Hight: unknown.Gender: unknown.Implantation: unknown.Explantation: unknown.Date of event: unknown.
 
Event Description
Additional information with the received product are available.Patient data: 45 years, 56 kg, 163 cm height.Implantation: (b)(6) 2020.Removal: (b)(6) 2020.
 
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Brand Name
PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.
Type of Device
HYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO KG
ulanenweg 2
potsdam, 14469
GM  14469
MDR Report Key10370431
MDR Text Key207553886
Report Number3004721439-2020-00151
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K141687
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/11/2023
Device Model NumberFX434-T
Device Catalogue NumberFX434-T
Device Lot Number20040180
Was Device Available for Evaluation? No
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age45 YR
Patient Weight56
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