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

Catalog Number	826850
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2025
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 nurse reported a cerelink sensor (id 826850) was implanted in a 54-year-old male patient who had experienced a hemorrhagic stroke involving the basal ganglia.On august 16, while the bedside nurse was repositioning the patient to change the linens, the cerelink monitor began alarming.The error code displayed was: ¿sensor or extension cable failure! disconnect and replace cable or sensor.¿ the nurse followed standard troubleshooting procedures.She confirmed that the ekg lead was intact and secure, though she replaced it as a precaution.She then powered off the monitor and rebooted it three times, but the same error code continued to appear.She checked the connection between the icp extension cable and the microsensor, which was secure.Despite replacing the icp extension cable, the error persisted, and the alarm continued to sound.The sensor was originally implanted on (b)(6) 2025, and removed on august 16, 2025.The patient did not exhibit any signs or symptoms related to the device issue.As of the latest update, the patient remains in critical but stable condition following the basal ganglia bleed.Additional information: implant location: "tunneled - parenchyma" was the integra/codman icp monitor connected to a patient monitor: "yes" was the patient lead always connected: "yes" description of the failure: "patient was being turning having their sheets changed.Alarm went off and error code, ¿sensor or extension cable failure!¿ disconnect and replace cable or sensor.¿.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cerelink sensor (id 826850) was returned for evaluation.Device history records - the product code 826850 with lot 7365394 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - catheter stretched 24.9 to 26.9 cm from connector end and internal wires broken.Catheter crimped 5.9, 16.8 and 24.4 cm from distal tip.Icp express: no transducer detected; cerelink monitor: sensor or extension cable failure.No further testing possible.Root cause analysis: the issue of the complaint was confirmed.The possible root cause for this issue reported by the customer could be due to design of icp probe is not robust, and integrity breaks down over time can also be due to mishandling of the catheter.
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP PROBE BASIC KIT
• Common Device Name: ICP MICRSOSENSORS - CERELINK
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1100 campus drive; 1100 campus drive; princeton NJ 08540
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 1100 campus drive; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22977789
• Report Number: 3013886523-2025-00232
• Device Sequence Number: 15747425
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: (01)10381780520689(17)280131(10)7365394
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 826850
• Device Lot Number: 7365394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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; ICP EXPRESS CABLE (ID 826845)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White