MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SARL CODMAN CERTAS PLUS PROGRAMMABLE VALVE INLINE SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 828805PL

Device Problem Improper Flow or Infusion (2954)

Patient Problems Headache (1880); Hematoma (1884); Failure of Implant (1924)

Event Date 09/27/2022

Event Type  Injury  

Event Description

Codman certas plus programmable valve with inline siphonguard malfunctioned.Programmed up to 6 but still causing patient to over drain.Patients condition declined resulting in headaches and a hematoma requiring surgery to remove the device.Fda safety report id # (b)(4).

• Brand Name: CODMAN CERTAS PLUS PROGRAMMABLE VALVE INLINE SIPHONGUARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SARL
• MDR Report Key: 15699318
• MDR Text Key: 302807030
• Report Number: MW5112968
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780521211
• UDI-Public: (01)10381780521211
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 828805PL
• Device Catalogue Number: 82-8805PL
• Device Lot Number: 6105017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female