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

Catalog Number	826850
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2026
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.The cerelink monitor registered multiple isolated abnormal readings, with several peaks reaching the 70 mmhg range as well as occasional low values around 3 mmhg.These events were brief and sporadic, not sustained and did not form a continuous trend in the data.No evd was implanted.Additional information: please confirm if the issue was detected before, during or after implantation: after.Did the patient experience any signs and symptoms due to product failure? unknown.Was the sensor replaced? sensor was not replaced.Was the sensor removed due to failure or monitoring was no longer needed? removed due to abnormal readings.With peaks reaching 70 mmhg.Was the integra/codman monitor connected to a patient monitor? yes.If yes, provide monitor make and model: phillips x3.Was the patient lead always connected? yes.
Additional Manufacturer Narrative
Updated fields: d1, d2a, d4, d9, g3, g6, h2, h3, h4, h6, h11.The cerelink sensor (id 826850) was returned for evaluation: device history record (dhr) - the product code 826850 with lot 7588268 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - received with a damaged serial number label.Received with sutures.The catheter was kinked at 25.1 cm and 103 cm from the proximal end.The icp express = 660, microsensor detected and zeroed without issue.No further testing.Root cause analysis - the exact issue reported by customer could not be confirmed as the device worked correctly.The possible root cause for the issue reported by the customer could be due to unstable sensor performance or incorrect selection of semiconductor components.

• Brand Name: CERELINK ICP PROBE BASIC KIT
• Common Device Name: ICP
• 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: 24199815
• Report Number: 3013886523-2026-00013
• Device Sequence Number: 18594297
• Product Code: GWM
• UDI-Device Identifier: 10381780520672
• UDI-Public: (01)10381780520672(11)251028(17)270930(10)7588268
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• 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): 03/27/2026

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: 7588268
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2025
• 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 SERIAL (B)(6).; MONITOR PHILLIPS X3.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown