MAUDE Adverse Event Report:; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8804

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem No Code Available (3191)

Event Date 05/01/2012

Event Type  Injury  

Event Description

Rep reported via email with a phone call follow up indicating that the account implanted a certas and the residents are having difficulty reading/programming the valve.They are experiencing difficulty in confirming the x-ray position and the programming tool is not working correctly.The device is sitll implanted.More information is expected.Additional information via a phone conversation explained that the event occurred post-op.The surgeon wanted to x-ray the patient to make sure the setting had not moved from the initial setting of 7.Hospital could not determine actual setting.We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures.In addition, a new complaint of (b)(4) was generated as additional follow-up reports could no longer be generated in the old system.Please refer to complaint (b)(4) 2012 a follow-up is being generated because the medwatch being reclassified to a serious injury.

Manufacturer Narrative

We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures.In addition, a new complaint of (b)(4) was generated as additional follow-up reports could no longer be generated in the old system.Please refer to complaint (b)(4) 2012 a follow-up is being generated because the medwatch being reclassified to a serious injury.

• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3770842
• MDR Text Key: 4433598
• Report Number: 1226348-2014-11409
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 82-8804
• Date Manufacturer Received: 04/21/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR