PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR FV427T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR FV427T manufactured by Christoph Miethke Gmbh & Co. Kg.

Event Text Entries

[188561381] When additional information becomes available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[188561382] It was reported that there is an issue with valve. The reporter indicated that a one year six month post-operative valve has a blockage and is under draining. The device was explanted. Additional event details is not available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004721439-2020-00073
MDR Report Key9868392
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-23
Date of Report2020-03-25
Date of Event2020-03-10
Date Mfgr Received2020-03-16
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJOERG KNEBEL
Manufacturer Street2 ULANENWEG
Manufacturer CityPOTSDAM D, 14469
Manufacturer CountryGM
Manufacturer Postal14469
Manufacturer G1CHRISTOPH MIETHKE GMBH & CO. KG
Manufacturer Street2 ULANENWEG
Manufacturer CityPOTSDAM D, 14469
Manufacturer CountryGM
Manufacturer Postal Code14469
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR
Generic NameHYDROCEPHALUS MANAGEMENT
Product CodeJXG
Date Received2020-03-23
Returned To Mfg2020-03-16
Model NumberFV427T
Catalog NumberFV427T
Lot Number20034681
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCHRISTOPH MIETHKE GMBH & CO. KG
Manufacturer Address2 ULANENWEG POTSDAM D, 14469 GM 14469


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-23

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