MAUDE Adverse Event Report: CODMAN CERTAS; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

On july 24, 2013, medtronic neurosurgery received a report from (b)(6) (patient family member) that the patient had a codman certas? valve that was explanted due to infection.The device catalog and lot numbers were not provided.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CERTAS
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN
• MDR Report Key: 17523659
• MDR Text Key: 321060795
• Report Number: MW5130607
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1