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)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cerelink sensor (id 826851) was not returned for evaluation as the product was discarded 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
This is 1 of 2 reports linked to mfg report numbers: 3013886523-2025-00199.A facility reported a cerelink sensor (id 826851) was placed on (b)(6) 2025, connected to a philips monitor cable (id 826881).The patient experienced a traumatic brain injury (tbi), who also had a drain and was intubated.The bedside nurse reported that the monitor stopped working when she laid a blanket over the patient.The patient had not been transported and was in a phenobarbital-induced coma.The account manager stated: "i asked the nurse to show me the trend screen, i didn¿t see the 'line' that typically indicates an esd shock, which i was instructed to look for.The nurse turned off the monitor and disconnected it from the patient for 30 minutes, then attempted to reconnect it, but was unsuccessful.The reference lead was attached.The nurse also tried swapping out the entire monitor and cord, but the sensor still did not work." it was also noted that "the nurse was very clear that this could have caused an injury if the sensor had not been in place for so long." due to the issue, the sensor was removed.Additional information: implant location: "parenchymal" hospital location of implant: "operating room (or)" cerelink monitor serial number: "unknown: one of our loaners for a trial" was a movement assistance device used? if yes, please specify.: "no ¿ a blanket was placed on the patient" did the patient receive an mri or ct scan before the failure occurred? "unknown" what was the mean icp before the ¿event¿? icp value: "unknown" what was the icp waveform quality before the ¿event¿? "good" what is the current mean icp? "unknown" what is the icp waveform quality after the ¿event¿? "good" when the failure occurred, was the cerelink monitor plugged into the wall? "yes" when the failure occurred, was the cerelink monitor connected to a patient monitor? "yes" make: "phillips" does the icp value on cerelink match the icp value on the patient monitor? "unknown" when the failure occurred, where was the cerelink monitor positioned? "iv pole" list all devices being used close to the cerelink monitor: "evd, ventilator" other devices implanted in the head? (shunt, evd, subdural drain).If yes, specify: "evd" were bipolar or monopolar forceps used while the sensor was plugged in? "no" provide a description of any unusual events or issues that occurred during the implantation or during the patient care: "blanket was laid on the patient and touched the connection" describe the quality of the insertion: "good.".

• 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: 22608772
• Report Number: 3013886523-2025-00198
• Device Sequence Number: 9737509
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 826851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/25/2025
• 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 CABLE (ID 826845); CERELINK ICP MONITOR POOL (ID 82680P); EXTERNAL VENTRICULAR DRAIN (EVD); VENTILATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown