MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSVII

Catalog Number XXX- OSVII

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Brain Injury (2219); Injury (2348)

Event Type  Injury  

Event Description

The father of the patient contacted directly integra and explained that his daughter got slit ventricle syndrome diagnosis and the osv was switched to another one.The patient has had the osv implanted for two and half years.The slit ventricle syndrome diagnosis appeared in autumn.No other information provided.

Manufacturer Narrative

Integra has completed their internal investigation on march 20, 2014.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: no device has been returned to integra for analysis.Dhr review; no traceability information was provided, no device history records review could be performed.Complaints history; from january 2013 ¿ march 20, 2017, a total of three (3) complaints (including this one) for osv ii valve systems have been reported for overdrainage.No adverse trend is observed.(b)(4).Conclusion: the exact root cause of the reported overdrainage could not be determined.Valve overdrainage is a known complication of valve therapy, identified in the product risk management and in the device labeling.

• Brand Name: OSVII
• Type of Device: OSVII
• 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: 6348995
• MDR Text Key: 67953448
• Report Number: 9612007-2017-00006
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX- OSVII
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 6 YR