MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION CODMAN CERTAS VP ADJUSTABLE BRAIN SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problem Defective Device (2588)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/12/2020

Event Type  Injury  

Event Description

Codman certas adjustable brain shunt caused build up of csf fluid and patient is in critical care.Recall 1.Could cause death.Fda safety report id# (b)(4).

• Brand Name: CODMAN CERTAS VP ADJUSTABLE BRAIN SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 10613052
• MDR Text Key: 209569624
• Report Number: MW5096986
• Device Sequence Number: 1
• Product Code: JXG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• 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): Hospitalization; Life Threatening; Disability
• Patient Age: 16 YR
• Patient Weight: 72