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U.S. Department of Health and Human Services

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

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INTEGRA NEUROSCICENCS IMPLANTS SA OSVII, CONNECTOR WITH ANTECHAMBER. N/A Back to Search Results
Catalog Number 909712
Device Problems Device Inoperable (1663); Insufficient Flow or Under Infusion (2182); Improper Device Output (2953)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation completed 12/8/2017. Only the ventricular catheter and the distal catheter were returned for investigation; the valve was not returned. Both catheters were patent, no obstruction was noted. Inspection of the catheters under magnification revealed no anomaly. The device history records of the osv ii ref 909712, lot 197979 were reviewed and did not reveal any anomaly. The complaint cannot be verified with the returned products, the most likely cause of the reported underdrainage after 2 weeks of implantation is a valve obstruction.
 
Event Description
It was identified that the valve was not draining a sufficient amount fifteen days after the valve was implanted. The valve stopped working for no apparent reason there was no patient injury reported. An unspecified revision/medical intervention was required.
 
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Brand NameOSVII, CONNECTOR WITH 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 Key6987076
MDR Text Key271297855
Report Number9612007-2017-00029
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 distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number909712
Device Lot Number0197979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
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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