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

Catalog Number	826850
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a cerelink sensor ((b)(6)) was implanted on (b)(6) 2025.The sensor was working for multiple days and was alarming "sensor failure" upon returning from mri when plugged into the patient cable.The nurse tried with every cord onsite, and they all alarmed sensor failure.The cords were tested independently with a demo sensor and they all worked.The sensor was removed and was not replaced as the patient did not require further monitoring.
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.
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 7503691 conformed to the specifications when released to stock.Failure analysis - a kink is present in the silastic, with additional kinks identified at approximately 22.8 cm, 38.9 cm and 55.8 cm.A small cut also noted on the catheter near 55.8 cm.Exposed wires are observed 588 cm from the proximal end.X-ray findings indicate broken wires.The issue of the complaint was confirmed.Root cause analysis - the possible root cause for this issue reported by the customer could be due to mishandling of the catheter.
Event or Problem Description
N/a.

• 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: 24130108
• Report Number: 3013886523-2026-00008
• Device Sequence Number: 20216785
• Product Code: GWM
• UDI-Device Identifier: 10381780520672
• UDI-Public: (01)10381780520672(11)250526(17)270430(10)7503691
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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 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: 01/02/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 34 KG