MAUDE Adverse Event Report: CERTAS INLIN VLV ONLY W/SPHNGD; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPS

Catalog Number 82-8804

Device Problems Use of Incorrect Control/Treatment Settings (1126); Pressure Problem (3012)

Patient Problem Headache (1880)

Event Type  Injury  

Event Description

Initial setting at 1.Re-adjusted to 2 at bedside on (b)(6) due to patient still not feeling well.Re-adjusted to 3 on (b)(6) 2012 due to patient still not feeling well (x-ray confirmed).Re-adjusted to 4 on (b)(6) 2012 due to patient still not feeling well (x-ray confirmed).Re-adjusted to 5 on (b)(6) 2012 due to patient not feeling well (x-ray confirmed).On (b)(6) determined that setting was actually at 4 and was re-set to 5.Patient advocate believed that the valve spontaneously changed pressure setting.Patient condition ok for now but not fully satisfactory (continued headaches).(b)(6) rep confirmed that the device is still implanted.Nothing will be returned.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).A follow-up is being generated due on the medwatch changing classification from malfunction to 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).A follow-up is being generated due to the medwatch changing classification from malfunction to serious injury.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3770912
• MDR Text Key: 4434571
• Report Number: 1226348-2014-11410
• 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
• Device Lot Number: CMNCVP
• Date Manufacturer Received: 04/21/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR