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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSVII, CONNECTOR W/O ANTECHAMBER N/A

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INTEGRA NEUROSCICENCS IMPLANTS SA OSVII, CONNECTOR W/O ANTECHAMBER N/A Back to Search Results
Catalog Number 909708S
Device Problems Partial Blockage (1065); Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Additional information received 21dec2017: the drainage was blocked. There was no other information provided.
 
Manufacturer Narrative
Investigation completed 17jan2018. Patency testing of the received osv ii valve did not reveal any anomaly. Pressure/flow testing showed the valve pressure/flow characteristics are below the specification. The valve modulus was then removed from its silicone elastomer housing and further microscopic examination revealed residues in the valve mechanism, on the pin and seat. No other anomaly was observed. The device history records of ref 909708s lot number 196598, serial number (b)(4) were reviewed and did not reveal any anomaly. The batch was manufactured in july 2016 and included 13 valves. No similar complaint was received for a product from this batch. The complaint is verified; the received valve is out of specification because of the presence of residue in the valve mechanism. These residue may explain the reported underdrainage (the valve was manufactured in 2016, duration of implantation is unknown).
 
Event Description
The device was explanted from the patient as it did not work. Additional information has been requested.
 
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Brand NameOSVII, CONNECTOR W/O ANTECHAMBER
Type of DeviceN/A
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 Key7100278
MDR Text Key263385227
Report Number9612007-2017-00031
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 11/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number909708S
Device Lot Number196598
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
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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