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Adverse Event Report

ELEKTA IMPLANTS, SA ORBIS SIGMA VALVE HYDROCEPHALUS SHUNT   back to search results
Catalog Number 909-612
Event Date 04/02/1998
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Report rec'd indicated that a 45 y/o female pt presenting with normal pressure hydrocephalus after sub-arachnoid hemorrhage was implanted with the valve on 12/10/97. According to the physician, the pt's ventricles did not decrease much (slit ventricle). After 3 months, there was no improvement of symptoms. The valve was explanted on 4/2/1998 and replaced.

 
Manufacturer Narrative

The following analysis has been performed on the returned product: visual examination: an orbis sigma valve without the original packaging was rec'd. The stopper plate was not in the appropriate position. Functional testing: patency testing of the valve via aspiration revealed no anomalies. The returned valve was tested in its returned configuration (with the moved stopper plate). The complete pressure/flow curve and the reflux test were within spec. Conclusion: the returned valve as rec'd was found within mechanical spec. The exact cause of the clinical symptoms could not be explained by the proper analysis. All products go through 100% test and visual inspection. Co supposes that the stopper plate moved during the explantation procedure (as initially suggested by the surgeon. ) the antechamber features 4 stops in order to prevent the migration of the stopper plate during normal implantation procedure. No corrective action is therefore deemed required.

 
Search Alerts/Recalls

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Brand NameORBIS SIGMA VALVE
Type of DeviceHYDROCEPHALUS SHUNT
Baseline Brand NameOSV W/15 CM VENT CATH & AC
Baseline Generic NameHYDROCEPHALUS VALVE
Baseline Catalogue Number909-612
Baseline Device FamilyORBIS SIGMA VALVE
Baseline Device 510(K) NumberK913636
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Date First Marketed12/12/1991
Manufacturer (Section F)
ELEKTA IMPLANTS, SA
2905 route des dolines
sophia antipolis
FRANCE F-06921
Manufacturer (Section D)
ELEKTA IMPLANTS, SA
2905 route des dolines
sophia antipolis
FRANCE F-06921
Manufacturer (Section G)
INTEGRA NEUROSCIENCES IMPLANTS S.A.
2905 route des dolines
sophia antipolis
FRANCE F-06921
Manufacturer Contact
anne bigeard
2905 route des dolines
sophia antipolis  
FRANCE   F-06921
(305) 824 -2532
334 939 55600
Device Event Key160650
MDR Report Key165056
Event Key155117
Report Number9612007-1998-00010
Device Sequence Number1
Product CodeJXG
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/14/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/01/2000
Device Catalogue Number909-612
Device LOT Number20497210
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/14/1998
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/14/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/1997
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 January 30, 2009

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