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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG SHUNTASSISTANT 20 HYDROCEPHALUS VALVES
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CHRISTOPH MIETHKE GMBH & CO. KG SHUNTASSISTANT 20 HYDROCEPHALUS VALVES Back to Search Results
Model Number FV424T
Device Problem Obstruction of Flow (2423)
Patient Problem Failure of Implant (1924)
Event Date 10/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). When additional information is received a follow up report will be submitted.
 
Event Description
It was reported by the healthcare professional "5y 7m po over drainage of the valve. Explanted. " all med watch submissions related to this patient are: 3004721439-2018-00272, 3004721439-2018-00273 (this report).
 
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Brand NameSHUNTASSISTANT 20
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 Key8063791
MDR Text Key126926461
Report Number3004721439-2018-00273
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 foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2012
Device Model NumberFV424T
Device Catalogue NumberFV424T
Device Lot Number4501157983
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/30/2018
Device Age11 YR
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2007
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: 11/13/2018 Patient Sequence Number: 1
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