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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.SPRUNG RESERVOIR HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA20 A.SPRUNG RESERVOIR HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX427T
Device Problem Infusion or Flow Problem (2964)
Patient Problems Patient Problem/Medical Problem (2688); Hydrocephalus (3272)
Event Date 11/18/2019
Event Type  Injury  
Manufacturer Narrative
Additional information has been requested. If additional information becomes available a follow up report will be submitted.
 
Event Description
The reporter indicated that an 18 day post-operative shunt over drained. Per the reporter, due to acoustic neuroma, the patient exhibited elevated protein value of cerebral spinal fluid. The protein value decreased after the tumor removal. Prior to receiving the meithke shunt the patient had a codman certas l-p shunt. The patient had a history of breast cancer and was on hemodialysis. The patient received a progav2. 0 on (b)(6) 2019 and soon after placing the shunt a over-drainage was exhibited. The shunt was removed on (b)(6) 2019. It was reported the patient passed away later (date was not provided). Clarification has been requested.
 
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Brand NamePROGAV 2.0 SYS W/SA20 A.SPRUNG RESERVOIR
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 Key9639661
MDR Text Key176746810
Report Number3004721439-2020-00027
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K141687
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX427T
Device Catalogue NumberFX427T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/18/2019
Was Device Evaluated by Manufacturer? Yes
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: 01/28/2020 Patient Sequence Number: 1
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