MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE 1L M BOLT

Catalog Number	826851
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
This is 4 of 5 reports linked to mfg report numbers: 3013886523-2026-00015, 3013886523-2026-00016, 3013886523-2026-00017.A facility reported that multiple sensors (id 826851) produced negative readings during the period of (b)(6) 2025, through (b)(6) 2026.Clinical troubleshooting was performed at the time of use.The lead was confirmed to be properly connected and in place, the microsensor depth was verified to be correct, and the device was zeroed according to instructions for use.Despite these actions, each implanted sensor continued to display negative readings.A total of five (5) microsensors were implanted and removed and replaced due to continued negative readings.No surgical delay occurred, and the patient did not experience any signs or symptoms, or adverse effects related to the device issue.After the fifth replacement and continued negative readings, monitoring was discontinued as it was no longer clinically needed.Additional information received: - implant location - "parenchyma" - was the integra/codman icp monitor connected to a patient monitor - "yes, cerelink monitor" - was the patient lead always connected - "yes".
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cerelink sensor (id (b)(4)) was returned for evaluation.Device history record (dhr) - the product code 826851 with lot 7365400 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the nylon catheter kink approximately 35.9 cm from distal tip.The icp express = 607, microsensor detected and zeroed without issue.The device passed electronic, noise and signal drift tests.The complaint was not confirmed.Root cause - the exact issue reported by customer could not be confirmed as the device worked correctly.The possible root cause for this issue reported by the customer could be due to unstable sensor performance or incorrect selection of semiconductor components.

• Brand Name: CERELINK ICP PROBE 1L M BOLT
• 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: 24278012
• Report Number: 3013886523-2026-00018
• Device Sequence Number: 8253843
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: (01)10381780520689(17)260228(10)7365400
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 826851
• Device Lot Number: 7573804
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CERELINK MONITOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White