MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE VALVE SEPAR

Catalog Number	828801PL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Dizziness (2194); Diaphoresis (2452); Convulsion/Seizure (4406)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reproted a certas valve (id (b)(6)) was implanted on (b)(6) 2024.Physician was unable to accurately change the setting of the shunt with multiple attempts from multiple programmers and different types of programmers as well (manual & electronic).The patient initially had shuffling of his gait with some improvement post implantation.On (b)(6) 2025, the patient arrived at the hospital with concerns of a seizure and symptoms of unsteadiness, lethargy, dizziness, and lightheadedness.Therefore, the valve was removed and replaced on (b)(6) 2025.The patient was discharged on (b)(6) 2025 and is currently stable.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.Additional health effect - clinical code1 e0204.
Additional Manufacturer Narrative
The certas valve (id 828801pl) was returned for evaluation.Device history record (dhr) - the product code 828801pl with lot 7464192 conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 6.The valve was visually inspected, and no defect was noted.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux and pressure.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to improper handling of the device at the time of investigation no programming issue was noted.
Event or Problem Description
N/a.

• Brand Name: CERTAS PLUS INLINE VALVE SEPAR
• Common Device Name: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21315441
• Report Number: 3013886523-2025-00023
• Device Sequence Number: 15674487
• Product Code: JXG
• UDI-Device Identifier: 10381780536987
• UDI-Public: (01)10381780536987(17)250930(10)7464192
• Combination Product (Y/N): N
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 828801PL
• Device Lot Number: 7464192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White