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

Catalog Number	826851
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a microsensor (id (b)(6)) was implanted on (b)(6) 2025.After transfer to the icu (intensive care unit), the icp (intracranial pressure) was reading negative numbers and occasionally fluctuated up to 73mmhg.A good waveform was present, but the icp reading was not accurate.On the analytics page it identifies the sensor as zeroed with the date and time.When going to the zero sensor screen there is a message saying, ¿sensor not zeroed¿.Therefore, the sensor was removed and replaced on (b)(6) 2025.The cable used was icp express cable (id (b)(6)).Additional information: - implant location: "parenchyma".- was the integra/codman icp monitor connected to a patient monitor: "yes".- if yes, provide patient monitor make & model: "philips (model unknown)".- was the patient lead always connected: "yes".
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, h6, h11.The microsensor (id 826851) was returned for evaluation.Device history record (dhr) - the product code 826851 with lot 7365428 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - based on the analysis and investigation, the issue of the complaint was not confirmed: foreign matter over sensor area.Catheter crimped 23 and 24 cm from connector.Icp express: 470 and 509 (after foreign matter removed from sensor); microsensor detected and zeroed without any issues; cerelink monitor: acceptable.The device passed electronic, noise and linearity/hysteresis tests.The issue of the complaint was not confirmed.Root cause analysis - 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.
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP PROBE 1L M BOLT
• 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: 22978147
• Report Number: 3013886523-2025-00243
• Device Sequence Number: 15810140
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: 10381780520689
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 03/31/2026
• Device Catalogue Number: 826851
• Device Lot Number: 7365428
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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: Male