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	Visual Disturbances (2140)
Date of Event	08/19/2024
Type of Reportable Event	Death
Event or Problem Description
2 of 2 reports.Other mfg report number: 3013886523-2024-00272.A facility reported: "sensor implanted on (b)(6) during the night 18-19 august, intra-ventricular pressure of patient increase suddenly but the value of icp read on cerelink monitor and on patient monitor did not move, it was stable.Sensor explanted on 19 august.".- clinical consequence: "brain involvement".- "they monitor alternatively the intra-ventricular pressure".- how did you detect that intra-ventricular pressure of patient increase? "bilateral mydriasis".- did the incident increase the patient's care time ? "the incident is responsible for the patient's death".Additional information has been requested.A supplemental report will be provided if additional information becomes available.
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, h6, h11.The cerelink monitor 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.
Additional Manufacturer Narrative
Root cause update: without the device return and the ability to analyze the waveform, trend and debug data, the ability to review hospital records, operative, follow up notes, etc., the root cause cannot be determined.We nonetheless hereafter attempt to make an assessment of potential causes based on the information we have.The allegation of device malfunction causal to patient demise from an inaccurate static reading approximately 15 to 16 days status post-implantation is unsubstantiated and highly unlikely as the sensor apparently functioned reliably through day 14.No element supports a conclusion that the medical device failed.On the contrary, the information available indicates that the device functioned appropriately: (1) cerelink was not reviewed, so no conclusion can be drawn regarding a malfunction; (2) the device functioned reliably through day 14, consistent with expected performance and known limitations of strain gauge sensors in vivo; and (3) the most likely explanation for the absence of elevated icp readings is a biological response such as encapsulation.This is precisely why protocols advocate for multimodal neuromonitoring, to ensure that foreign body reactions do not compromise data interpretation and to support clinical decision-making beyond the recommended monitoring period.
Event or Problem Description
N/a.

• 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 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: 20169779
• Report Number: 3014334038-2024-00186
• Device Sequence Number: 7040515
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2025

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: 826820
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 02/03/2025; 06/25/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 02/21/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3014334038 -8/23/2022-00
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown