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

Catalog Number	826850
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a nurse was preparing to synchronize cerelink to bedside monitor and accidentally zeroed the icp sensor (while implanted).The sensor was placed on (b)(6) 2025, and removed on (b)(6) 2025.There were no complications reported for the patient.Additional information: monitor used - clk2116186 cable used - 826845 sensor implant location: parenchyma was the integra/codman icp monitor connected to a patient monitor: yes if yes, provide patient monitor make & model: phillips intellivue was the patient lead always connected: yes.
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, h6, h11.The micrsosensors - cerelink (id:(b)(6)) was not returned for evaluation as the product was discarded, and 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, the possible root cause for the reported complaint could be due to low pulsatility (less than or equal to 1.5 mmhg peak to peak) allows sensor to be re-zeroed after implantation and personnel unaware of proper use of the device.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.

• 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: 22072376
• Report Number: 3013886523-2025-00115
• Device Sequence Number: 13102146
• Product Code: GWM
• UDI-Device Identifier: 10381780520672
• UDI-Public: 10381780520672
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 826850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CERELINK CABLE (ID 826845).; MONITOR: CLK2116186.; PATIENT MONITOR: PHILLIPS INTELLIVUE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White