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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 10 A.PRECHAMBER HYDROCEPHALUS VALVES

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 10 A.PRECHAMBER HYDROCEPHALUS VALVES Back to Search Results
Model Number FV439T
Device Problem Obstruction of Flow (2423)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Patient information: sex, weight, and height: unknown. Implant date: unknown. Explant date: unknown. When additional information is received, a follow up report will be submitted.
 
Event Description
It was reported by the healthcare professional "after implanted for a period of time, the patient was checked back into the hospital for pressure adjustment. But it was found unable to adjust the pressure. The valve pressure data was maintained with the same as last time. The device was explanted. ".
 
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Brand NamePROGAV SYS PED.W/SA 10 A.PRECHAMBER
Type of DeviceHYDROCEPHALUS VALVES
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
Manufacturer (Section G)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8111573
MDR Text Key128629108
Report Number3004721439-2018-00278
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K103003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model NumberFV439T
Device Catalogue NumberFV439T
Device Lot Number20027089
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/05/2018
Device Age3 YR
Event Location No Information
Date Manufacturer Received11/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2015
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: 11/28/2018 Patient Sequence Number: 1
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