MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / JOHNSON & JOHNSON CERTAS PLUS; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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

Patient Problems Emotional Changes (1831); Unspecified Infection (1930); Irritability (2421); Sleep Dysfunction (2517)

Event Date 04/20/2020

Event Type  Injury  

Event Description

Certas plus shunt was implanted on (b)(6) 2020.About 2 weeks later he began having severe mental status changes, agitation, insomnia that lasted for days, and other things.Finally weeks later csf was cultured and it was infected.I am very concerned that the shunt wasn't functioning due to the mental status changes, and no signs of infection at that time.Fda safety report id# (b)(4).

• Brand Name: CERTAS PLUS
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / JOHNSON & JOHNSON
• MDR Report Key: 10239275
• MDR Text Key: 197998314
• Report Number: MW5095385
• 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: Unknown
• Type of Report: Initial
• Report Date: 07/01/2020

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 109