MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP. CERTAS PROGRAMMABLE SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problems Reset Problem (3019); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 10/03/2019

Event Type  Injury  

Event Description

The pt had a left ventriculoperitoneal shunt malfunction while implanted in her brain.Multiple attempts of resetting the valve without success.The setting would be changed to 2, then it would quickly return to the setting of it.The implant was removed and replaced within the pt.Fda safety report id# (b)(4).

• Brand Name: CERTAS PROGRAMMABLE SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP. ; plainsboro NJ 08536
• MDR Report Key: 9244825
• MDR Text Key: 164238091
• Report Number: MW5090693
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Patient Age: 27 YR