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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

Certas shunt valve fixed at 2, could not be reprogrammed.Patient had to have shunt revision.Certas valve was quarantined.Rep made aware, stated that there was a known issue with some of the valves.

• Brand Name: 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: 13590676
• MDR Text Key: 286058563
• Report Number: 13590676
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 365 DA
• Patient Sex: Male