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

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  

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.

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.

• Brand Name: OSVII, CONNECTOR WITH ANTECHAMBER.
• Type of Device: N/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 Key: 6987076
• MDR Text Key: 91373763
• Report Number: 9612007-2017-00029
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K140722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 909712
• Device Lot Number: 0197979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR