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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SHUNTSYSTEM PRO GAV

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SHUNTSYSTEM PRO GAV Back to Search Results
Model Number FV441T
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2018
Event Type  Injury  
Manufacturer Narrative
Investigation: optical inspection: no significant deformations or damage of the valves were detected during the visual inspection. Permeability test: a permeability test has shown that both valves are permeable. Adjustment test: the progav valve was tested and is not adjustable throughout the normal range. Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected. However, the braking force could not be examined because the valve is no longer adjustable. Computer controlled test: to test the opening pressure, we use a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow. The progav valve is not operating within acceptable tolerances. Results: finally, we have dismantled the valves. Inside the progav valve we have found a slight build-up of substances (likely protein). Based on our investigation, we confirm that the valve is non-adjustable and the valve is operating in an over-drainage state, likely due to the deposits observed inside the valve. As described in out literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). It was reported that the valve became dysfunctional , no further information.
 
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Brand NamePROGAV SHUNTSYSTEM
Type of DevicePRO GAV
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam, D-144 69
GM D-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 Key7251321
MDR Text Key134102809
Report Number3004721439-2018-00016
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K103003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/20/2021
Device Model NumberFV441T
Device Catalogue NumberFV441T
Device Lot Number20032157
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date07/17/2018
Event Location No Information
Date Manufacturer Received07/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2016
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: 02/08/2018 Patient Sequence Number: 1
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