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

Catalog Number	826631
Medical Device Problem Codes	Break (1069); No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a microsensor (id 826631) was implanted on (b)(6) 2026.The patient's microsensor was disconnected for a ct scan during the second day of intracranial pressure (icp) monitoring.After returning to the ward and attempting to reconnect, it was found that the connection could not be established, with the icp monitor continuously indicating no probe connection.The issue persisted even after switching to another icp monitor.On the third morning, while changing the dressing, the doctor discovered that the microsensor coiled under the dressing and had broken.The microsensor was explanted on (b)(6) 2026, due to breakage.The monitor and cable used were icp express, 220 volt monitor (id 826635) and 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, h11.The microsensor (id 826631) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history records (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The microsensor (id 826631) was returned for evaluation.Device history review: the product code 826631 with lot 7347130; sn a547019, conformed to the specifications when released to stock.Failure analysis: based on the supplier analysis and investigation, the issue of the complaint was confirmed: the catheter was received cut at 68.6 cm from the proximal end.No further testing.Root cause analysis: based on the failure analysis, the complaint was confirmed by the supplier.The possible root cause for this issue reported by the customer could be due to mishandling of the catheter.

• 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: 24333881
• Report Number: 3013886523-2026-00023
• Device Sequence Number: 15898069
• Product Code: GWM
• 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,Distributor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2026

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: 7347130
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 05/26/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/17/2026; 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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: ICP EXPRESS CABLE (ID 826636); ICP EXPRESS, 220 VOLT MONITOR (ID 826635)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: Asian