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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2025
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 cerelink sensor (id: 826850) was implanted on (b)(6) 2025.While preparing the patient for transport to computed tomography (ct) scan, the bedside monitor pressure box was moved to the transport monitor, and staff were unable to get the transport monitor to synchronize with the cerelink monitor.While the nurse was troubleshooting, the patient¿s icp drifted down from the mid-teens to 0¿1.They changed the cerelink monitor, but the icp remained unchanged.They then placed the bedside monitor pressure module back into the bedside monitor but again were not able to synchronize with the cerelink.The icp remained at 0¿1, and they decided to zero the sensor (which was done per the time/date on the cerelink monitor).Although they successfully synchronized the cerelink to the bedside monitor, they did not wait for the bedside monitor¿s digital readout to match the reference number sent from the cerelink.The icp was still reading 0¿1, but when the patient was stimulated or coughed, the icp increased to around 6, and the icp waveform appeared normal.It was confirmed that the reference lead was securely attached and that the sensor had been re-zeroed.The patient was never moved from the bed and did not go to ct at that time.The nursing staff had zeroed the sensor while attempting to troubleshoot.The patient did not experience any signs or symptoms.Due to the issue, the sensor was removed on (b)(6) 2025 and was not replaced.The patient¿s status remained stable.Additional information: monitor used and serial number - cerelink ¿ two monitors used to r/o monitor issue ¿ serial numbers unknown sensor information kit used (ex: 826850) 826850.Serial number (located on backside of sensor) unknown, asked that it be saved when discontinued ¿ but it was discarded lot number (located on the unit carton/box) unknown.Implant location (ex: parenchyma) parenchyma was the integra/codman icp monitor connected to a patient monitor - yes.A.If yes, provide patient monitor make & model - phillips intellivue was the patient lead always connected - yes, connected securely description of the failure: icp dropped from mid-teens to 0-1.Prior to caregivers contacting me they plugged the sensor into a different cerelink monitor and also re-zeroed the sensor (while implanted).The reference lead was securely attached.I explained to the bedside nurse, pa, and md that the cerelink displayed mean icp could no longer be considered accurate since the sensor was re-zeroed while in place.The physician kept the sensor in and asked the nurses to add 13 to the displayed mean.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The cerelink sensor (id 826850) 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.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.

• 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: 22069411
• Report Number: 3013886523-2025-00113
• Device Sequence Number: 15621380
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 09/12/2025
• 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); CERELINK MONITOR (ID 826820)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White