MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE 1L P BOLT; ICP MICRSOSENSORS - CERELINK

Model Number	826852
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 microsensor was implanted and connected to a cerelink monitor.After a few hours a screen error appeared "sensor or cable damaged".Medical staff changed the cable and the monitor.All started working; however, the screen error reappeared and the sensor was explanted.
Additional Manufacturer Narrative
Additional information received: the patient is a 16 year-old male.The sensor was implanted to treat a severe traumatic brain injury and it was not replaced.The patient is in rehabilitation and not responsive.
Additional Manufacturer Narrative
Complaint sample was returned for evaluation: failure analysis - the issue of the complaint was not confirmed.No visible damage to the millar sensor, catheter material, or connector.Icp express passed with reading 465.The device passed electronic, noise, linearity/hysteresis, and signal drift tests.Root cause could not be determined as the device worked correctly.However, the possible root cause of the defect reported by the customer could be due to improper use or excessive force on product; physical strength of product unfit for intended use.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Root cause update: the possible root cause of the defect reported by the customer could be due to unstable sensor performance or incorrect selection of semiconductor components.
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP PROBE 1L P BOLT
• Common Device Name: ICP MICRSOSENSORS - CERELINK
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12739941
• Report Number: 3013886523-2021-00465
• Device Sequence Number: 11901617
• Product Code: GWM
• UDI-Device Identifier: 10381780520696
• UDI-Public: 10381780520696
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/19/2022

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 Model Number: 826852
• Device Catalogue Number: 826852
• Device Lot Number: 4738880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 11/05/2021; 03/01/2022; 04/14/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/24/2021; 03/15/2022; 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2020
• 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