MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE 1L M BOLT; ICP MICRSOSENSORS - CERELINK

Catalog Number	826851
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 facility reported a cerelink sensor (id 826851) was implanted on (b)(6) 2025.No monitor issues were observed until june 5; after repositioning the patient, the cerelink icp monitor displayed an error message indicating a problem with either the icp extension cable or the icp sensor.Another monitor and cable were substituted, but the issue persisted.The sensor was then replaced with a new one, after which the icp reading returned to the expected baseline level with an appropriate waveform.Troubleshooting indicated that the issue was due to a malfunctioning icp sensor.Additional information sensor information: kit used: 826851 (metal skull bolt), serial number: (b)(6), lot number: unknown, implant location: bolted sensor.(parenchyma) was the integra/codman icp monitor connected to a patient monitor: yes a.If yes, provide patient monitor make & model: phillips (unknown model) was the patient lead always connected: yes description of the failure: sensor was working fine for approximately 5+ days until nurse turned patient and then noticed error message on monitor saying that there was an issue with either the sensor or extension cable.New sensor was implanted and issue was solved.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cerelink sensor (id 826851) was returned for evaluation.Device history record (dhr) - the product code 826851 with lot 7365412, sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the issue of the complaint was confirmed.Foreign matter over sensor area.Catheter stretched 4.3 ¿ 6 and 6.8 ¿ 8.8 cm from proximal end.Internal wires broke where the catheter was stretched.The intracranial pressure (icp) express read ¿no transducer detected¿.No further resting possible.Root cause analysis - the possible root cause for this issue reported by the customer could be due to the design of icp probe connector is not robust and could also be due to mishandling of the catheter.
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP PROBE 1L M BOLT
• 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: 22310408
• Report Number: 3013886523-2025-00156
• Device Sequence Number: 20996520
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: (01)10381780520689(17)260228(10)7365412
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: 02/28/2026
• Device Catalogue Number: 826851
• Device Lot Number: 7365412
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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: PHILLIPS (UNKNOWN MODEL).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown