MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC. CODMAN CERTAS VP SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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

Patient Problem Death (1802)

Event Date 08/19/2018

Event Type  Death  

Event Description

Vp codman certas shunt malfunctioned causing pt's death.On mri and ct scans shunt looked fine.Autopsy revealed cause of death 100 percent vp codman certas adjustable shunt.Unfortunately we did not believe the pt, until after death.Fda safety report id# (b)(4).

• Brand Name: CODMAN CERTAS VP SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC.
• MDR Report Key: 9311383
• MDR Text Key: 166043554
• Report Number: MW5091000
• 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: Physician
• Type of Report: Initial
• Report Date: 11/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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): Death
• Patient Age: 20 YR
• Patient Weight: 49