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Adverse Event Report

CORDIS BIOT CORDIS ORBIS SIGMA VALVE HYDROCEPHALUS VALVE   back to search results
Catalog Number 90S-706
Event Date 02/28/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

Two of co's ventricular shunts using a "y" connection had been implanted in a 50 y/o male pt. Approx one mo post implant, one shunt of the two valve system was not functioning. Subject unit was explanted and replaced uneventfully with another valve ii. Visual exam: co's valve without the original packaging was received. Some puncture holes were noted in the antechamber. Functional testing: patency testing of the valve via aspiration did not reveal any anomalies. Valve was tested in its original silicone boot. Complete pressure/flow curve and reflux tests were within specs. Valve was within mechanical spec. Ventricular catheter was not obstructed. Cause for reported difficulty could not be determined, but it does appear to be valve related.

 
Event Description

The valve did not work and was explanted.

 
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Brand NameCORDIS ORBIS SIGMA VALVE
Type of DeviceHYDROCEPHALUS VALVE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CORDIS BIOT
parc de sophia-antipolis
route des dolines 2905
valbonne
FRANCE F-06560
Manufacturer (Section D)
CORDIS BIOT
parc de sophia-antipolis
route des dolines 2905
valbonne
FRANCE F-06560
Manufacturer (Section G)
INTEGRA NEUROSCIENCES IMPLANTS S.A.
2905 route des dolines
sophia antipolis
FRANCE F-06921
Device Event Key78308
MDR Report Key78686
Event Key74091
Report Number9612007-1997-00010
Device Sequence Number1
Product CodeJXG
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/27/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/01/1999
Device Catalogue Number90S-706
Device LOT Number20796244
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/28/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/28/1997
Event Location Hospital
Date Manufacturer Received02/28/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/1996
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on December 31, 2008

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