MAUDE Adverse Event Report: JOHNSON & JOHNSON / INTEGRA LIFESCIENCES CERTAS CODMAN ; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problem Missing Information (4053)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2018

Event Type  malfunction  

Event Description

I had a certas-codman ventricular-peritoneal shunt implanted (b)(6) 2017 from johnson and johnson at the (b)(6).This replaced a medtronic strata valve.Medtronic always supplies an id card for their implanted devices with technical info for pts to show radiologists and physicians for safety concerns during mra exams and tsa agents at airports as some devices trigger alarms.I have never received a card for the certas-codman valve, so i called j&j only to find out, the unit was sold to integra life sciences.I called integra but have not heard back from integra medical inquiry division.My complaint is with j&j and integra life sciences for failing to provide implanted device id cards.

• Brand Name: CERTAS CODMAN
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): JOHNSON & JOHNSON / INTEGRA LIFESCIENCES
• MDR Report Key: 8090645
• MDR Text Key: 128191837
• Report Number: MW5081503
• 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: Patient
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 91