MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD NEUROMONITOR BASIC KIT; ICP

Catalog Number	826631
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a microsensor (id 826631) was implanted on (b)(6), 2026.Postoperatively, the patient returned to the ward with unstable intracranial pressure (icp) readings, which fluctuated abnormally from 30 mmhg to over 300 mmhg.Therefore, the physician stopped the monitoring and the microsensor was consequently removed on (b)(6), 2026.The patient is stable.The sensor was used with monitor: icp express, 220 volt (id 826635) and cable: icp express cable (id 826636).
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The microsensor (id 826631) was returned for evaluation.Device history review: the product code 826631 with lot 7624426 sn unknown, conformed to the specifications when released to stock.Failure analysis: received with the serial number label damaged.Icp express = 526, microsensor detected and zeroed without issues.The device passed electronic, noise and signal drift tests.The issue of the complaint was not confirmed.Root cause analysis: the exact issue reported by customer could not be confirmed as the device worked correctly.The possible root cause for this issue reported by the customer could be due to unstable sensor performance or incorrect selection of semiconductor components.

• Brand Name: NEUROMONITOR 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 ; +1(609)936-2319
• MDR Report Key: 25485470
• Report Number: 3013886523-2026-00144
• Device Sequence Number: 9930462
• Product Code: GWM
• UDI-Device Identifier: 10381780520412
• UDI-Public: (01)10381780520412(17)301031(10)7624426
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 826631
• Device Lot Number: 7624426
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown