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

Catalog Number	826631
Medical Device Problem Codes	No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2025
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 a microsensor (id 826631) was implanted on (b)(6) 2025.Three days after implantation, the sensor could not be detected after performing a magnetic resonance imaging (mri) and showed -99mmhg.Therefore, the physician retrieved the device and stopped monitoring.The patient is stable.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 microsensor (id 826631) was returned for evaluation.Device history record (dhr) - the product code 826631 with lot 7347164 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the catheter crimped 14cm from connector.The icp express = 499; microsensor detected and zeroed without any issues.The device passed electronics, noise, linearity/hysteresis 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.A possible root cause for the problem reported could be linked to the patient displacement or to the mri exam.As mentioned in the ifu "exposure to electrostatic discharge (esd) energy could damage the device.Avoid the use of materials that could generate esd during patient movement and transport, e.G., nylon transfer boards with bedding".Compatibility of implantable catheter-tipped pressure transducers with magnetic resonance imaging (mri) has not been determined.
Event or Problem Description
N/a.

• 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: 22202044
• Report Number: 3013886523-2025-00141
• Device Sequence Number: 17831576
• Product Code: GWM
• UDI-Device Identifier: 10381780520412
• UDI-Public: (01)10381780520412(17)290131(10)7347164
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/12/2025

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: 7347164
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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 - CABLES (ID 826636); ICP EXPRESS - MONITOR (ID 826635)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian