MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE BASIC KIT; ICP MICRSOSENSORS - CERELINK

Catalog Number	826850
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
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
This is 2 of 2 reports linked to mfg report numbers: 3013886523-2025-00285.A facility reported a cerelink sensor (id 826850 - lot 0227512) failed to measure the patient¿s intracranial pressure (icp).The sensor was placed 3 cm into the brain parenchyma on (b)(6) 2025, with an icp reading of 12 mmhg.After disconnection from the monitor, the patient was transferred to the trauma intensive care unit (icu).Upon reconnection in the icu, the sensor displayed negative icp values that did not correlate with the patient¿s clinical presentation.The sensor was then removed and replaced bedside in the icu on (b)(6) 2025.However, the second sensor (id 826850 - lot 0229419) showed an initial spike icp reading of 17-24, and then instantly dropped to 0-2 and did not climb up from here until 7-8 hours later where it leveled out at 11.The second sensor was not removed due to failure.Reason for sensor placement: traumatic brain and spine injury, due to intraparenchymal hematoma on sensor placement side, contralateral epidural hematoma, spinal fracture.Based on information provided it is unknown if there was an issue with the cable used.It is also unknown if the patient experienced any signs and symptoms due to sensor issue.Additional information received: implant location (ex: parenchyma): parenchyma was the integra/codman icp monitor connected to a patient monitor (yes/no): no was the patient lead always connected (yes/no): no.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h11.The cerelink sensor (id 826850) was returned for evaluation.Device history review: the product code 826850 with lot 7495602 sn (b)(6), conformed to the specifications when released to stock.Failure analysis: the issue of the complaint was confirmed: foreign matter over sensor area.Balance high due to foreign matter, removed foreign matter and balance was normal.Icp express: 552, cerelink monitor acceptable.The device passed electronic, noise, linearity/hysteresis and signal drift tests.Root cause analysis: the root cause for the issue reported by the customer is use related (film residue), as the sensor passed all tests after cleaning.
Event or Problem Description
Na.

• Brand Name: CERELINK ICP PROBE BASIC KIT
• 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: 23379901
• Report Number: 3013886523-2025-00286
• Device Sequence Number: 8899868
• Product Code: GWM
• UDI-Device Identifier: 10381780520672
• UDI-Public: (01)10381780520672(17)261231(10)749560
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: 826850
• Device Lot Number: 0229419
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CERELINK ICP MONITOR (ID 826820) SN: (B)(6); CERELINK ICP MONITOR (ID 826820) SN: (B)(6)
• Patient Sex: Male
• Patient Ethnicity: Hispanic