MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE BASIC KIT; ICP MICRSOSENSORS - CERELINK

Catalog Number	826850
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/25/2025
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
2 of 2 reports.Other mfg report number: 3013886523-2025-00187.A facility reported that two cerelink sensors (id 826850) showed an error message in the monitor mentioning cable failure.On (b)(6) 2025, cerelink sensor #1 was implanted.Nursing documentation reports sensor is not functional and so the patient transfers to icu without icp monitor.On (b)(6) 2025, the patient undergoes a second procedure to implant "microsensor #2", sensor is working after implantation.On (b)(6) 2025, the patient comes back from mri and error message appears on the monitor "sensor or extension cable failure! disconnect and replace cable or sensor".After replacing the extension cable, they had the same error message.Note: during field visit on june 6, 2025, i.T.V.(nurse counselor) mentions that the sensor was not coiled in loops on a dry gauze on patient's head as ifu demands for mri.She says she saw a part of the censor's wire hanging straight, and the other part was coiled in loops on a dry gauze on patient's head.On june 26, 2025, dr.(b)(6) reports that 2 sensors had problems working correctly and that the error message on the monitor mentions cable failure.Medical staff connected the patient's "microsensor #2" to another cerelink monitor (monitor (b)(4)) and extension cable and the error message is still appearing.The patient did not experience any signs or symptoms; however, the physician reiterated that patient did not have icp monitoring during the episode.The first microsensor was removed on (b)(6) 2025.The second microsensor was removed and replaced.According to the nursing team, the patient's lead was always connected, and the implant location was the parenchyma.The patient's current condition was not available.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The cerelink sensors (id 826850) was not returned for evaluation as the product was discarded and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.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
N/a.

• Brand Name: CERELINK ICP PROBE BASIC KIT
• 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: 22546085
• Report Number: 3013886523-2025-00190
• Device Sequence Number: 12943415
• Product Code: GWM
• UDI-Device Identifier: 10381780520672
• UDI-Public: 10381780520672
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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 Catalogue Number: 826850
• Device Lot Number: 7468769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 ID 826820 - (B)(4).; CERELINK MONITOR ID 826820 - (B)(4).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown