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

Catalog Number	826851
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cerelink sensor was not returned for evaluation (as per customer, product not available) 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.
Event or Problem Description
A physician reported a cerelink sensor (b)(6) was implanted and working appropriately.After returning from computed tomography (ct) scan the nurse plugged in the microsensor and zeroed the microsensor while it was in the head.The zero button for the microsensor in the cerelink monitor allowed zeroing even though the sensor was implanted.Due to the issue, the sensor was removed and replaced.The patient was discharged, and intracranial pressure (icp) measuring is no longer needed.Clinical questionnaire: monitor used and serial number: cerelink (b)(6).Sensor information: a.Kit used: (b)(6).D.Implant location: parenchyma.Was the integra/codman icp monitor connected to a patient monitor (yes/no): yes.A.If yes, provide patient monitor make & model: philips.Was the patient lead always connected (yes/no): yes.Description of the failure including: provider had placed a cerelink microsensor prior.The microsensor was zeroed and working appropriately.After returning from ct the nurse plugged in the microsensor and zeroed the microsensor while it was implanted.The zero button (for the microsensor) was made available even though it was implanted and pressure was being applied to the sensor by the icp.

• 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: 21357510
• Report Number: 3013886523-2025-00032
• Device Sequence Number: 20952788
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 826851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 02/11/2025
• 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: CERELINK ICP EXT CABLE (B)(6).; PHILIPS MONITOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown