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

Catalog Number	826631
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2025
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 physician reported a microsensor (b)(6) was implanted on (b)(6) 2025 due to a head injury.On (b)(6) 2025, when it was disconnected for dressing change and reconnected, the value fluctuated from 200 to negative.The power was restarted and replaced with another icp express; however, the issue was not resolved; therefore, the sensor was removed and replaced with another (b)(6) on (b)(6) 2025.As of (b)(6) 2025, the new icp was functioning without problems.Based on the information provided, the monitor and cable information are unknown.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h11.The microsensor (id 82663) 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 the manipulation of the catheter at the time of the dressing change.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.The microsensor (id 82663) was returned for evaluation.Failure analysis: based on the supplier analysis and investigation, the issue of the complaint was confirmed: catheter crimped 3 cm from distal end.Catheter crimped and has a hole punctured through 5.7 cm from distal tip, icp express: zeroing error.No further testing possible root cause analysis: the possible root cause for this issue reported by the customer could be due to mishandling of the catheter.
Event or Problem Description
Na.

• 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: 22912061
• Report Number: 3013886523-2025-00223
• Device Sequence Number: 21148877
• 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 Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/25/2025

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: 08/13/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 12/10/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/24/2025; 12/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ICP EXPRESS UNIT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown