MAUDE Adverse Event Report: INTEGRA LIFE SCIENCES CORPORATION CODMAN CERTAS PROGRAMMABLE SHUNT (PUT IN BY UNCLE WEDSTWOOD); SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Complaint, Ill-Defined (2331); Disability (2371)

Event Date 07/02/2018

Event Type  Injury  

Event Description

Codman certas shunt causes serious disability and sickness to my son.Fda safety report id# (b)(4).

• Brand Name: CODMAN CERTAS PROGRAMMABLE SHUNT (PUT IN BY UNCLE WEDSTWOOD)
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENT
• Manufacturer (Section D): INTEGRA LIFE SCIENCES CORPORATION
• MDR Report Key: 9362873
• MDR Text Key: 167774759
• Report Number: MW5091244
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 25 YR
• Patient Weight: 82