MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE 1L M BOLT; DEVICE, MONITORING, INTRACRANIAL PRESSURE

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	11/28/2025
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
A facility reported a cerelink sensor (id (b)(6)) was implanted on (b)(6) 2025, and functioning normally until the patient returned from a ct scan on (b)(6) 2025.The cerelink monitor was displaying negative intracranial pressure (icp) values (approximately ¿5 mmhg).The values increased when the patient¿s head of bed was lowered toward a supine position.All troubleshooting steps were completed, including disconnecting and reconnecting the microsensor from the patient extension cable, power off and on the cerelink monitor, replacing the patient extension cable, and swapping the monitor.The icp values began to rise afterward.The ct scan indicated that the microsensor was located in a ¿shallow area¿ and ¿nearing the outside of the brain.The microsensor was explanted on (b)(6) 2025, due to unreliable numbers.Additional information: - implant location (ex: parenchyma): parenchyma.- was the integra/codman icp monitor connected to a patient monitor: yes.- if yes, provide patient monitor make & model: philips monitor intellivue.- 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 826851) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history records (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
Na.

• Brand Name: CERELINK ICP PROBE 1L M BOLT
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• 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: 23957137
• Report Number: 3013886523-2025-00330
• Device Sequence Number: 18544495
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: (01)10381780520689(17)270228(10)7517720
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 826851
• Device Lot Number: 7517720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• 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 MONITOR.; EXTENSION CABLE (B)(4).; PHILIPS MONITOR INTELLIVUE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown