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

Catalog Number	826631
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
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 microsensor (id: 826631) was implanted.The icp express, 220 volt (id: 826635) showed 175 mmhg.However, all post-examination indicators of the patient were normal.Then the physician connected the microsensor to another icp monitor; it still showed 170 mmhg, which was inconsistent with the patient¿s status.Therefore, the sensor was removed on (b)(6) 2026, and monitoring was stopped.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The microsensor (id 826631) was returned for evaluation: device history record (dhr) - the product code 826631 with lot 7525928 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the issue of the complaint was not confirmed: received with sutures, catheter kinked 15.5 cm and 28.4 cm from the distal tip.Debris encapsulated within the rtv.Icp express = 493, microsensor detected and zeroed without issue.The device passed electronic, noise and signal drift tests.Root cause analysis - the exact issue reported by customer could not be confirmed as the device worked correctly.However, the possible root cause of the defect reported by the customer could be due to incorrect set-up of device.

• 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 ; 6099362319
• MDR Report Key: 24198280
• Report Number: 3013886523-2026-00010
• Device Sequence Number: 17516658
• Product Code: GWM
• UDI-Device Identifier: 10381780520412
• UDI-Public: (01)10381780520412(17)300228(10)7525928
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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 Expiration Date: 02/28/2023
• Device Catalogue Number: 826631
• Device Lot Number: 7517694
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 03/22/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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: ICP EXPRESS (ID: 826635); ICP EXPRESS CABLE (ID: 826636)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian