MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE BASIC KIT; ICP MICRSOSENSORS - CERELINK

Catalog Number	826850
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a microsensor (id 826850) was implanted on (b)(6) 2025 in a 12 year old male admitted for intractable headaches.Icp values 8-9mmhg and appropriate waveform.There was a waveform the entirety of the implantation.One hour after insertion icp values trending negative.It is not known if patient lead was connected at time of insertion.Patient lead was confirmed connected on (b)(6) 2025.Icp values maintained negative mmhg readings throughout the day ((b)(6) 2025).Patient sitting up: -10 to -13mmhg.Patient at 30-45 hob -2 to -1mmhg.Patient flat icp values 3-4mmhg.Patient had generalized headache, however no new deficits with negative readings.Monitor and cable were replaced and negative readings persisted.Mri of brain was completed prior to insertion ((b)(6) 2025), showing normal ventricles of the brain.Patient has ventriculoperitoneal shunt placed as infant and has not had revision during lifetime.Technology surrounding cerelink icp monitor and microsensor: iphone (within 1 foot), video game console within 3 feet, iv pump, phillips bedside monitor.
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cerelink microsensor (id 826850) was returned for evaluation.Device history record (dhr) - the product code 826850 with lot 7495597 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the catheter crimped 18.5 and 19 cm from connector end.Icp express = 518; cerelink monitor acceptable; zeroed without any issue.The device passed electronic, noise 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.The possible root cause for this issue reported by the customer could be due to unstable sensor performance or incorrect selection of semiconductor components.
Additional Manufacturer Narrative
Updated fields: d6b, g3, g6, h2, h3, h11.Additional information received: the sensor was removed on (b)(6) 2025, and was not replaced.The patient is in stable condition.
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP PROBE BASIC KIT
• Common Device Name: ICP MICRSOSENSORS - CERELINK
• 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: 22012752
• Report Number: 3013886523-2025-00099
• Device Sequence Number: 5342691
• Product Code: GWM
• UDI-Device Identifier: 10381780520672
• UDI-Public: (01)10381780520672(17)261231(10)7495597
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 826850
• Device Lot Number: 7495597
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 07/09/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/24/2025; 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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
• Patient Age: 12 YR
• Patient Sex: Male