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

Catalog Number	826631
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2025
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 that on (b)(6) 2025, the nursing team initiated intracranial pressure (icp) monitoring for a patient diagnosed with acute severe traumatic brain injury, utilizing an icp sensor (id 826631) integrated with an icp monitoring device.On (b)(6) the nurse observed a loss of data transmission from the icp monitor.The monitoring device was promptly replaced; however, the issue persisted.The root cause suspected: a covert fracture of the icp sensor lead wire (confirmed during post-event analysis).After replacing the icp sensor with a new unit, stable icp monitoring was successfully restored.The monitor and cable used were icp express - monitor (id 826635) and icp express - cables (id 826636).
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The icp sensor (id 826631) was not returned for evaluation as the product is not available for return as per customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.However, the possible root cause for the reported complaint could be due to improper use or excessive force on product; physical strength of materials unfit for intended use.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: NEUROMONITOR BASIC KIT
• Common Device Name: ICP MICROSENSORS
• 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: 22283737
• Report Number: 3013886523-2025-00155
• Device Sequence Number: 8327451
• Product Code: GWM
• UDI-Device Identifier: 10381780520412
• UDI-Public: (01)10381780520412(17)280930(10)7306025
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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 Catalogue Number: 826631
• Device Lot Number: 7306025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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 Age: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian