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

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	06/13/2025
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 sensor (id 826631) was implanted and failed three days after implantation.Fifteen minutes after postural change, the icp displayed -99.After adjusting the zero point, it displayed 198.After that, the device kept displaying the value above 50.Therefore, the device was explanted and replaced.The ct scan showed no signs of the intracranial pressure rising.In addition, the icp was displaying the normal value right before the incident.The patient did not experienced signs and symptoms due to sensor malfunction.
Additional Manufacturer Narrative
Updated fields: d4, d6b, d9, g3, g6, h2, h3, h4, h6, h11 the sensor (id (b)(6)) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to unstable sensor performance or incorrect selection of semiconductor components.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, h11.Failure analysis - based on analysis and investigation, the issue of the complaint was not confirmed: foreign matter over sensor area.Catheter crimped (where suture tied) 12 and 14 cm from distal tip.Icp express: 491 and 504 (after foreign matter removed from sensor), microsensor detected and zeroed without any issues.The device passed electronic, noise and linearity/hysteresis tests.Root cause analysis - based on the failure analysis, the exact issue reported by customer could not be confirmed as the device worked correctly.The possible root cause for this issue reported by the customer could be due to unstable sensor performance or incorrect selection of semiconductor components.

• 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: 22310853
• Report Number: 3013886523-2025-00160
• Device Sequence Number: 12908083
• Product Code: GWM
• UDI-Device Identifier: 10381780520412
• UDI-Public: 10381780520412
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 826631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 10/24/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/05/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown