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	Insufficient Information (4580)
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 physician reported a sensor (id 826631) was implanted on an unknown date.After placement, the sensor did not display values properly while measuring pressure in the icu.Although the zero point was readjusted, a negative value continued to be displayed.The sensor remained responsive, as the readings changed when the bed angle was adjusted.Therefore, the sensor was removed on an unknown date.According to information provided, it is unclear whether the patient experienced any signs or symptoms related to the product issue.The status of the patient is unknown.It is also unknown if monitoring was discontinued due to a product issue or because it was no longer necessary.
Event or Problem Description
N/a.
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 7503674 sn a600801, conformed to the specifications when released to stock.Failure analysis - the issue of the complaint was not confirmed.No visible damage to the millar sensor or connector.The catheter crimped 1.9 cm from distal tip, sticky residue along catheter body.Icp express: 492, microsensor detected and zeroed without any issues.The device passed electronic, noise and signal drift tests.Root cause analysis - the exact issue reported by customer could not be confirmed as the device worked correctly.However, the possible root cause of the defect reported by the customer could be due to incorrect set-up of device.

• 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: 23322770
• Report Number: 3013886523-2025-00275
• Device Sequence Number: 10637951
• Product Code: GWM
• UDI-Device Identifier: 10381780520412
• UDI-Public: (01)10381780520412(17)300228(10)7503674
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: 7503674
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• 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