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	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a cerelink sensor (id 826850) was placed on (b)(6) 2025 for intracranial pressure (icp) monitoring.The patient was there to evaluate the need for a vp shunt and was awake, the kid and his dad were playing and ¿shocked¿ one another with static and now the monitor has gone berserk reading 136 with no waveform.The reference lead was not one and had not been connected for an unknown period of time.Electrostatic discgarge (esd) was suspected.Troubleshooting included connecting the reference lead and disconnecting the sensor for 10¿15 minutes to allow any ion build up to dissipate; the icp later displayed a waveform but remained elevated in the 80s.Monitor replacement did not resolve the issue.Therefore, the sensor was removed and replaced on (b)(6) 2025.Additional information: cable used: phillips patient monitor and icp extension cable.Monitor used and serial number: cerelink icp monitor ¿ d10 monitor.Implant location: parenchyma.Was the integra/codman icp monitor connected to a patient monitor: yes (philips).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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cerelink sensor (id 826850) was returned for evaluation: device history record (dhr) - the product code 826850 with lot 7482185 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the catheter received with suture tied and crimped catheter 143 cm from distal tip.Internal wires damaged from crimp.The serial number label pulled off from the connector.The complaint was confirmed.Root cause analysis - the possible root cause for this issue reported by the customer could be due to unstable sensor performance or incorrect selection of semiconductor components and could also be due to mishandling of the catheter.

• 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: 23657880
• Report Number: 3013886523-2025-00311
• Device Sequence Number: 14658792
• Product Code: GWM
• UDI-Device Identifier: 10381780520672
• UDI-Public: (01)10381780520672(17)261130(10)7482185
• 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
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 826850
• Device Lot Number: 224132
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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 ICP MONITOR ¿ D10 MONITOR; ICP EXTENSION CABLE; PHILIPS PATIENT MONITOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Race: White