MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP MONITOR; ICP MONITOR-CERELINK

Catalog Number	826820
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported: "when using the cerelink monitor, the error sign for the cable appeared.The client had to change to the icp express system." additional information received: could you please provide more details about dysfunction (negative icp values before error message)? answer : after the implant of the sensor, when connecting the cable to the sensor the reported error message came out.Will the monitor be returned to integra for analysis? answer : no.Was the new or old cerelink cable used during the dysfunction? answer : new (no ecg connection in the or due to the positioning of the patient) was the monitor already reworked? answer : yes.After how many time of use the dysfunction appeared? answer : immediately.Were there any consequences for the patient (as injury)? answer : no.Were there any late medical actions due to dysfunction? answer : 15mins ca.Was the patient an elderly person, an adult, a child or a baby? answer : adult (ca 65yo).What are product reference, lot and serial number of sensor? answer : (b)(6) (no lot available).Where was the sensor implanted (ex : parenchyma) ? answer : parenchyma.Was the integra/codman icp monitor connected to a patient monitor ? if yes, please provide make and model? answer : no.Was the patient lead always connected? answer : yes.What was user doing (e.G., powering unit, zeroing sensor, setting alarm, downloading data) answer : implant.What was happening with the patient (e.G., transport, mri, ct).Answer : sensor implant.Could you please confirm if error message was ¿sensor or extension cable failure! disconnect and replace cable or sensor¿ ? answer : yes.Could you please explain us why the ecg connection could not be used? did the patient have no place to add the connection (damaged skin)? answer : they have space issues in the or and the ecg cable seems to be too short for them to connect it to the patient while implanting the sensor.We agreed they are going to try to connect it on the arm.Could you please confirm if the sensor (the first implanted) stayed implanted when they switched to icp express or they tried to implant 2nd sensor? answer : yes, although during the training we explained the importance of not connecting the already implanted sensor on a different machine (icp express), they decided to proceed this way and they communicated us that the data reported were reliable.After they reported this info, we underlined again the fact that this is not the right procedure.
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, h4, h6, h11.Cerelink cable 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, however, a potential root causes include, misuse of the cerelink cable.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.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 18399252
• Report Number: 3014334038-2023-00198
• Device Sequence Number: 14146574
• Product Code: GWM
• UDI-Device Identifier: 10886704075622
• UDI-Public: 10886704075622
• 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
• Report Date (Section B): 06/26/2024

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?: 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): Follow-Up
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown