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

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	02/18/2026
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
A facility reported a cerelink sensor (id 826850) failed while in use.Looking through the error logs it was found multiple "sensor warning: mean icp value exceeded the valid range:" messages.The recorded values are between -84 to -360mmhg.Patient required an mri scan of head.Icp monitor in situ which required gauze and coiling away from the skin pre scan.This was done incorrectly and needed re-doing multiple times leading to higher risk of dislodgement.Patient admitted to hospital with a intraparenchymal bleed and has the icp monitor in still (24 days) due to continuing icp spikes and hydrocephalus.Mri completed safely however icp now reading negative numbers and is not sutured in.?accidentally dislodged or moved slightly.Additional information received: - sensor reference? 826850 - sensor lot number? unknown - extension cable lot number? unknown - date of event? 18/02/2026 - was the patient lead (electrode of extension cable) always connected to the patient? yes - implant location - parenchymal - did the issue lead to any patient injury / complications or death?answer : no - did the issue lead to a critical delay in patient care ? no - what was the user doing (e.G., powering unit, zeroing sensor, setting alarm, downloading data)? preparing to mri - what was happening with patient (e.G., transport, mri, ct)? mri - what did medical team do to solve the issue? eventually the probe was secured properly for mri, then subsequently the probe failed.- if applicable: can you please confirm if the replacement with new sensor was successful ? no replacement done.
Additional Manufacturer Narrative
Additional information received: the sensor was not replaced, medical staff deemed that monitoring was no longer necessary.

• Brand Name: CERELINK ICP PROBE BASIC KIT
• 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: 24586643
• Report Number: 3013886523-2026-00059
• Device Sequence Number: 13071302
• Product Code: GWM
• UDI-Device Identifier: 10381780520672
• UDI-Public: (01)10381780520672(11)251106(17)271031(10)7604716
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2026

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
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/24/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/10/2026; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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: 826820P - CERELINK ICP MONITOR, POOL.
• Patient Sex: Unknown