MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ICP SENSOR CATHETER KIT; ICP MICROSENSORS

Catalog Number	826633
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2025
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: 826633) was implanted on (b)(6) 2025.Two days after the procedure, the microsensor dislodged, therefore, it was retrieved.The sensor was not replaced, and there is no information on whether the monitoring stopped due to the product problem or if monitoring was no longer necessary.The patient's status is stable.The monitor and cable used were icp express, 220 volt (id: 826635) and icp express cable (id: 826636).
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The microsensor (id (b)(6)) was returned for evaluation and a photo was provided and evaluated: device history record (dhr) - the reported product¿s lot or serial number.No anomalies were identified that occurred during the manufacture or packaging of the device.Failure analysis - the complaint can be confirmed via customer image showing the tubing dislodged from the rest of the device.Device was additional tested by supplier for failure analysis the sensor passed all functional tests.Root cause analysis - the potential causes of the separation include patient movement or torque applied when adjusting the device.
Event or Problem Description
N/a.

• Brand Name: ICP SENSOR CATHETER 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: 22013043
• Report Number: 3014334038-2025-00061
• Device Sequence Number: 5228771
• Product Code: GWM
• UDI-Device Identifier: 10381780520436
• UDI-Public: 10381780520436
• Combination Product (Y/N): N
• PMA/510(K) Number: K991222
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 826633
• Device Lot Number: 7249936
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ICP EXPRESS CABLE (ID (B)(6)).; ICP EXPRESS, 220 VOLT MONITOR (ID (B)(6)).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian