MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION CODMAN CERTAS SHUNT VALVE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problem Defective Device (2588)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/11/2020

Event Type  malfunction  

Event Description

Shunt malfunction.Certas shunt valve.Patient had this valve inserted.He came to the operating room 4 weeks later to have the valve removed and replaced.The valve was successfully replaced with another type.The implanted valve was replaced due to a malfunction.

• Brand Name: CODMAN CERTAS SHUNT VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 12099344
• MDR Text Key: 259418064
• Report Number: 12099344
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1