MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP MONITOR

Catalog Number	826820
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
2 of 3 reports.Other mfg report numbers: 3013886523-2026-00035, 3006697299-2026-00014.A facility reported a codman sensor (id 826850), a codman monitor (id 826820) and a cerelink extension cable (id 826845) were used to monitor intracranial pressure in a patient in intensive care unit.The system was working fine and suddenly stopped reading showing error "possible input failure".Patient required a new sensor insertion.Additional information received: date of event ¿ 5 feb 2026 if used with cerelink: was the patient lead (electrode of extension cable) always connected to the patient? yes implant location? sub-dural did the issue lead to any patient injury / complications or death? no what was the user doing (e.G., powering unit, zeroing sensor, setting alarm, downloading data)? error came up shortly after implantation.What was happening with patient (e.G., transport, mri, ct)? in icu can you please confirm that the replacement was successful and only the sensor is defective in this case (no issue with monitor and extension cable)? both monitor and sensor were isolated and a new monitor and sensor was used.
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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11 the cerelink monitor was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - this device is with new software versions for digital (3.01.07) and analog (3.00.06) boards.The device is working good without errors.Battery back door has small crack at the screw hole and needs to be replaced.Before 10 months, the li-ion battery was replaced.At this time, only functional and est testing will be performed.Root cause - there was no fault found in the monitor.A potential root cause of the reported error may have been related to inadequate sensor or cable connection.

• Brand Name: CERELINK ICP MONITOR
• Common Device Name: ICP
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 24469566
• Report Number: 3014334038-2026-00017
• Device Sequence Number: 21172381
• Product Code: GWM
• UDI-Device Identifier: 10381780533788
• UDI-Public: 10381780533788
• Combination Product (Y/N): N
• PMA/510(K) Number: K183406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 826820
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown