MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP MONITOR; ICP MONITOR-CERELINK

Catalog Number	826820
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
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
This is 2 of 3 reports linked to mfg report numbers: 3013886523-2024-00152, 3013886523-2024-00153.A facility reported a cerelink microsensor (id 826851) was implanted on (b)(6) 2024 and was used with the cerelink cable (id (b)(6) ) for intracranial pressure (icp) monitoring.It was stated that they were getting a sensor/cable failure message.The icp went from 18 to 150, then the error message appeared.The reference lead was attached and was instructed to move and replace the electrocardiogram (ecg) patch, so that the lead would peel away or come off.The sensor had been in use for approximately 10 hours and was alarming for 10-15 minutes.The cerelink monitor (id 826850) and extension cable were switched out and disconnected the sensor for 30 minutes.They attempted it again, but the error remained.On (b)(6) 2024, the sensor was removed and replaced.The patient is in a critical condition.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cerelink monitor (id 826820) was returned for evaluation.Device history record (dhr) - the batch records were reviewed for any anomalies or reports related to the finished device, and none were identified.Failure analysis - during service, the icp cable has been removed from the icp connector.The cerelink has been tested and passed all tests and checks.Root cause analysis - incoming inspection revealed, duplicated the problem -monitor not being able to zero because the icp extension cable was not properly connected to icp connector.It was difficult to remove it, and it was not possible to zero the unit.
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP MONITOR
• Common Device Name: ICP MONITOR-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: 19391931
• Report Number: 3014334038-2024-00101
• Device Sequence Number: 7799926
• Product Code: GWM
• UDI-Device Identifier: 10381780533788
• UDI-Public: 10381780533788
• Combination Product (Y/N): N
• PMA/510(K) Number: K183406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: 826820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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 Sex: Unknown