MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP EXT CABLE

Catalog Number	826845
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
1 of 3 reports.Other mfg report numbers: 3013886523-2026-00035, 3014334038-2026-00017.A facility reported a codman sensor (id 826850), a codman monitor (id 826820) and a cerelink extension cable (id 826845) were used to monitor intracranial pressure in a patient in intensive care unit.The system was working fine and suddenly stopped reading showing error "possible input failure".Patient required a new sensor insertion.Additional information received: date of event ¿ 5 feb 2026 if used with cerelink: was the patient lead (electrode of extension cable) always connected to the patient? yes implant location? sub-dural did the issue lead to any patient injury / complications or death? no what was the user doing (e.G., powering unit, zeroing sensor, setting alarm, downloading data)? error came up shortly after implantation.What was happening with patient (e.G., transport, mri, ct)? in icu can you please confirm that the replacement was successful and only the sensor is defective in this case (no issue with monitor and extension cable)? both monitor and sensor were isolated and a new monitor and sensor was used.
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 cerelink cable was returned for evaluation: dhr - no anomalies during the manufacture or packaging that could be associated with the complaint incident was observed failure analysis - the device is working good without errors.Root cause - no fault found.The device was confirmed to be operating correctly with no errors identified.

• Brand Name: CERELINK ICP EXT CABLE
• 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: 24469565
• Report Number: 3006697299-2026-00014
• Device Sequence Number: 15792959
• Product Code: GWM
• UDI-Device Identifier: 10381780520665
• UDI-Public: 10381780520665
• Combination Product (Y/N): N
• PMA/510(K) Number: K183406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

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: 826845
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown