MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC / INTEGRA LIFESCIENCES PRODUCTION CORP CODMAN CERTAS PLUS PROGRAMMABLE VALVE; SHUNT CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problem Defective Component (2292)

Patient Problem Malaise (2359)

Event Date 12/09/2018

Event Type  Injury  

Event Description

This device was implanted with the understanding that it was comparable to the certas that was previously used with this patient.The device failed in days after implantation resulting in the patient becoming increasingly ill and the valve needing replaced.

• Brand Name: CODMAN CERTAS PLUS PROGRAMMABLE VALVE
• Type of Device: SHUNT CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC / INTEGRA LIFESCIENCES PRODUCTION CORP
• MDR Report Key: 8336909
• MDR Text Key: 136739431
• Report Number: MW5084009
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Weight: 31