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

Catalog Number	826845
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
2 of 3 reports.Other mfg report numbers (same event, same patient, different products): 3014334038-2024-00080 3013886523-2024-00118 a facility reported that after 5 days using the cerelink ventricular microsensor, the cerelink monitor displayed an error message: 'replace cable or sensor¿, after trying to switch off and plugging out and in the cable, the alarm remained on the screen.Ecg connection was on and the monitor was charging all the time.Medical staff stop monitoring, and started monitoring with ct scans.The patient was monitored for intracranial hypertension caused by traumatic brain injury with continuous monitoring until the dysfunction of the sensor.
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
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.Cerelink cable was returned for evaluation: dhr - documentation was reviewed and no anomalies during the manufacture or packaging that could be associated with the complaint incident was observed.Failure analysis - cable passed all testing and meets specification.Root cause - no fault found.Possible root cause: issue may be with monitor or sensor rather than cable.

• Brand Name: CERELINK ICP EXT CABLE
• Common Device Name: CERELINK - CABLES
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19143551
• Report Number: 3006697299-2024-00042
• Device Sequence Number: 7335223
• Product Code: GWM
• UDI-Device Identifier: 10381780520665
• UDI-Public: (01)10381780520665(11)231002(10)7310490
• Combination Product (Y/N): N
• PMA/510(K) Number: K210993
• 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): 09/05/2025

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?: 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): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2023
• 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