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

Catalog Number	826851
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare facility reported a cerelink sensor (id (b)(6)) was implanted on (b)(6) 2025.Following implantation, the intracranial pressure (icp) reading spontaneously dropped to 0, and no waveform was observed.There was no change in the patient's condition, and no manipulation of the monitor was performed.The icp monitor was changed; however, the same 0 icp reading and absence of waveform persisted.This issue continued for a duration of 40 hours.Notably, the first icp monitor was used the same issue within 24 hours of sensor insertion.The sensor was removed on (b)(6) 2025, and was not replaced.Additional information: - implant location - "parenchyma".- was the integra/codman icp monitor connected to a patient monitor - yes - phillips mx800.- was the patient lead always connected - "yes".- description of the failure: - "reading low/negative numbers.Minimal if no change during care and repositioning, suspicious of accuracy.Spontaneous 0 with no waveform." - "inserted (b)(6), 1st negative numbers viewed aug 14 for 4 hrs., then 3 more time".
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, d8, d9, g6, h1, h2, h3, h4, h6, h11.The cerelink sensor (826851) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint could be due to unstable sensor performance or incorrect selection of semiconductor components.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g6, h1, h2, h3, h6, h11.The cerelink sensor (id 826851) was returned for evaluation.Device history record (dhr) - the product code 826851 with lot 7503665 sn (b)(6), conformed to the specifications when released to stock.Failure analysis: the issue of the complaint was not confirmed.Foreign matter over sensor area.Catheter crimped 6.3 cm from distal end, crimped at bottom of connector and silastic damaged.Icp express: 600 (before cleaning foreign matter).Microsensor detected and zeroed without any issues, cerelink monitor: acceptable.Icp express: 554 (after cleaning foreign matter).Part of the sn label was missing and there was a sticky residue over the connector.The device passed electronic, noise and signal drift tests.Root cause analysis - the exact issue reported by customer could not be confirmed as the device worked correctly.The possible root cause for the issue reported by the customer could be due to unstable sensor performance or incorrect selection of semiconductor components and could also be due to mishandling of the catheter.

• 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 ; 4900 charlemar dr, dock b; cincinnati, OH 45227 ; 6099362319
• MDR Report Key: 22978148
• Report Number: 3013886523-2025-00235
• Device Sequence Number: 9430512
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: (01)10381780520689(17)270131(10)7503665
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2026

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
• Device Lot Number: 7503665
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 10/17/2025; 12/18/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/07/2025; 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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: PHILLIPS MONITOR - MX800
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown