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

Model Number	828805PL
Health Effect - Clinical Codes	Headache (1880); Hematoma (1884); Failure of Implant (1924)
Date of Event	09/27/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SARL
• MDR Report Key: 15699318
• Report Number: MW5112968
• Device Sequence Number: 4932481
• Product Code: JXG
• UDI-Device Identifier: 10381780521211
• UDI-Public: (01)10381780521211
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female