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

Catalog Number	826845
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
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
2 of 3 complaints (same patient, same event, different products).Other mfg report numbers: 3014334038-2024-00147 3013886523-2024-00202.A facility reported a patient had a decompressive craniectomy and was rolled to relieve pressure areas.No disconnection of cables or monitor alarms.A short time after the monitor message was "sensor or extension cable failure".Medical staff was unable to resolve as screen would not change, and was unable to monitor icps.All trouble shooting carried out correctly, as the sales representative was there personally to troubleshoot.New monitor and cables connected which displayed the same screen.Sensor surgically removed from patient.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The cerelink extension cable was returned for evaluation: failure analysis - visually inspected and there is no visual defect.Connected to an icp probe and engineering monitor and the monitor displayed the icp pressure and no errors.Root cause - no fault found.Possible root cause based on customer reported failure: issue may be with sensor.

• 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 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: 19722015
• Report Number: 3006697299-2024-00102
• Device Sequence Number: 8206607
• 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): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 06/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown