MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD UNKNOWN CERELINK; ICP MICRSOSENSORS - CERELINK

Catalog Number	XXX - CERELINK
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
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
A facility reported a cerelink sensor (b)(6) was implanted and error message "sensor or extension cable failure" appeared spontaneously without reason.The patient was not moved.Medical staff changed the monitor and cable without success.Therefore, the sensor was explanted and replaced.Additional information received: the new sensor worked without changing monitor or cable.Electrode of extension cable was placed on the patient during all monitoring, intraparenchymal localization in the left frontal region, no clear delay (fiber changed in 30 minutes).
Additional Manufacturer Narrative
The cerelink sensor was returned for evaluation: dhr - conformed to the specifications when released to stock.Failure analysis - the issue of the complaint was not confirmed: - unknown foreign residue covering sensor area that is not part of the manufacturing process.- catheter crimped 17.5cm from distal end.- icp express = 535; cerelink monitor acceptable.- microsensor was detected and zeroed without any issues, did not receive an ¿error message¿.- no further testing.Root cause - the exact root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause of the defect reported by the customer could be ¿unstable sensor performance or incorrect selection of semiconductor components¿.
Event or Problem Description
N/a.

• Brand Name: UNKNOWN CERELINK
• Common Device Name: ICP MICRSOSENSORS - CERELINK
• 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: 21384769
• Report Number: 3014334038-2025-00020
• Device Sequence Number: 20925165
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: (01)10381780520689(17)260430(10)7378396
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• 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): 06/06/2025

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: 04/30/2026
• Device Catalogue Number: XXX - CERELINK
• Device Lot Number: 216863
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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 Sex: Unknown