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

Catalog Number	826851
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a cerelink sensor alarm with message to change the sensor or patient cable after patient returned from a ct scan (1 hour post-scan).The customer changed the patient cable and the issue persisted.The monitor had a spontaneous loos of power, the monitor was replaced and the sensor failure was confirmed.Therefore the sensor was removed.Additional information: - monitor used and serial number: "cerelink (b)(6)" - sensor information - kit used: "826851" - implant location: "parenchyma' - was the integra/codman icp monitor connected to a patient monitor: "yes" - if yes, provide patient monitor make & model: "phillips mx800" - was the patient lead always connected: "yes" - what was happening with patient (e.G., transport, mri, ct): "patient had returned from ct scan, unit functioning normally until 1hr post-scan.¿microsensor failure¿ spontaneously alarmed.No change to patient condition (sedated, supine), no user interference.".
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h11.The microsensor was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history records (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint is improper placement of the skull clamp, resulting in slippage.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.
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP PROBE 1L M BOLT
• 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: 22864811
• Report Number: 3013886523-2025-00220
• Device Sequence Number: 9338670
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: 10381780520689
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 826851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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: 826820-CERELINK MONITOR; 826845-CERELINK CABLE; 826881-CERELINK CABLE; PHILLIPS MX800-PATIENT MONITOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown