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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSVII VALVE UNIT, 2 CONNECTORS WITH ANTECHAMBER

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INTEGRA NEUROSCICENCS IMPLANTS SA OSVII VALVE UNIT, 2 CONNECTORS WITH ANTECHAMBER Back to Search Results
Catalog Number 909700
Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2017
Event Type  malfunction  
Event Description
The shunt was removed as it did not function. Additional information received on 21mar2017 with the following: there was no patient injury reported. The event did not lead to increase surgery time. The patient had slow dilatation of ventricle; the cause of insufficient drainage of csf flow. No other information provided.
 
Manufacturer Narrative
Additional information received on april 10th 2017 : the date of valve implantation was unknown. The patient is a (b)(6) female with an underlying medical condition of multiple meningitis and "hamartoma of mesencephalon".
 
Manufacturer Narrative
Integra has completed their internal investigation on may 3, 2017 results: evaluation of returned device; patency testing showed the received valve was patent (no obstruction). The valve was tested and found within pressure/flow specifications. Each osv ii valve is pressure/flow tested at the end of the manufacturing process. The involved valve osv ii ref 909700, sn (b)(4) was tested within pressure/flow specifications at time of manufacture. Dhr review; the device history records review of the osv ii valve ref 909700, lot # 0188400, s/n (b)(4) were reviewed and did not reveal any anomaly. Complaints history; upon review of integra¿s complaint system from january 2014 ¿ march 24, 2017, a total of nine (9) complaints (including this one) for osv ii valve systems have been reported for obstruction after the implantation procedure. Over (b)(4) units of osv ii valve systems have been sold from january 2014 to march 6, 2017, resulting in a complaint occurrence rate of approximately (b)(4). No adverse trend is observed. Conclusion: as the received valve was found within pressure/flow specifications, the complaint is not verified: the valve testing does not explain the reported obstruction. Given the available information, the exact root cause of this event could not be determined.
 
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Brand NameOSVII VALVE UNIT, 2 CONNECTORS WITH ANTECHAMBER
Type of DeviceOSVII
Manufacturer (Section D)
INTEGRA NEUROSCICENCS IMPLANTS SA
2905 route des dolines
2905 route des dolines
sophia antipolis F-069 21
FR F-06921
Manufacturer (Section G)
INTEGRA NEUROSCICENCS IMPLANTS SA
2905 route des dolines
sophia antipolis F-069 21
FR F-06921
Manufacturer Contact
rowena bunuan
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key6435373
MDR Text Key71217751
Report Number9612007-2017-00007
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K140722
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number909700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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