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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV; HYDROCEPHALUS SHUNT
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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV; HYDROCEPHALUS SHUNT Back to Search Results
Model Number PRID00002125
Device Problems Decrease in Pressure (1490); Program or Algorithm Execution Failure (4036)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Patient information unknown: age, gender, height, weight.Date of event: unknown.Implant date: (year 2012).When additional information is received a follow up report will be submitted.
 
Event Description
It was reported to the company sales representative "the shunt valve is stuck on open and has a history of reprogramming." the patient symptoms are consistent with the shunt malfunction of low pressure with the inner cranial pressure monitor.No patient injury reported.Additional information has been requested; however, not yet received.If additional information is received a follow up report will be submitted.
 
Manufacturer Narrative
The device was not released for investigation (signature of the surgeon required), and no evaluation was able to be performed.
 
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Brand Name
PROGAV
Type of Device
HYDROCEPHALUS SHUNT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM  14469
MDR Report Key8333467
MDR Text Key135957401
Report Number3004721439-2019-00030
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPRID00002125
Device Catalogue NumberPRID00002125
Was Device Available for Evaluation? No
Distributor Facility Aware Date01/25/2019
Date Manufacturer Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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