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

Catalog Number	826820
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	03/06/2024
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 1 of 2 reports linked to mfg report numbers: 3013886523-2024-00095.A facility reported a patient experienced negative readings of a cerelink monitor (826820) and cerelink sensor (b)(6).The patient had a reading of 28mmhg, and phenobarbital was given at 0600.The icp dropped as expected but continued to -2 then slowly increased to the patient¿s expected icp at 2pm.The event occurred again in march 13.A medication was administered for high icp at 0700 and the patient experienced a drop progressively to negative -2.The medication could have caused this drop but because the icp usually in the range of (b)(4) , making it not confident in the negative values given.The cerelink monitor (826820) and cerelink sensor (b)(6) were used along with cable (7298286).There is no issue with the cable used.The cerelink sensor (b)(6) was implanted on (b)(6) 2024, and was explanted on (b)(6) 2024, as the sensor was no longer required for treatment the patient did not experienced any signs and symptoms due to negative readings, and no longer treatment was required.Additional information received: was the integra/codman icp monitor connected to a patient monitor: yes a, if yes, provide patient monitor make & model: philips was the patient lead always connected: yes description of the failure including: a.What was user doing (e.G., powering unit, zeroing sensor, setting alarm, downloading data) b.What was happening with patient (e.G., transport, mri, ct): answer: no patient procedure/interventions at time of negative numbers.Icp dropped to 1 to -2 for at 0900 for 3-4 h prior to coming back to 10-12 where values were approximately prior this.Treatment for high icp (28) given at 0600.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cerelink monitor (id 826820) was not returned for evaluation 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 MONITOR
• Common Device Name: ICP MONITOR-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 08540 ; 6099362319
• MDR Report Key: 19018504
• Report Number: 3014334038-2024-00063
• Device Sequence Number: 15492915
• 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): 02/07/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CABLE (7298286); CERELINK SENSOR (826851)
• Patient Sex: Unknown