MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD NEUROMONITOR BASIC KIT; ICP MICROSENSORS

Catalog Number	826631
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a microsensor (id 826631) was properly displaying value until noon of the day after implantation.When the device was reconnected after transferring the patient for diagnostic imaging, the value was not displayed at all.Therefore, the sensor was explanted and replaced with a new device.According to information provided, the cable and the monitor used along with the sensor are unknown.It is also unknown if the patient experienced signs and symptoms due to device issue.
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
The microsensor (id 826631) was returned for evaluation.Failure analysis ¿ the issue of the complaint was confirmed: - catheter stretched 12.5cm from connector end.- catheter received with sutures 11.7 & 29cm from distal tip.- internal wires damaged from being stretched and suture too tight.- no further testing possible.- the complaint was confirmed.Root cause analysis - the supplier could determine the cause of the issue to be mishandling of the catheter.The probable root cause for this issue could be the ¿transit manipulation¿ or ¿unstable sensor performance or incorrect selection of semiconductor components¿.
Event or Problem Description
N/a.

• Brand Name: NEUROMONITOR BASIC KIT
• Common Device Name: ICP MICROSENSORS
• 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: 19731515
• Report Number: 3013886523-2024-00206
• Device Sequence Number: 8274537
• Product Code: GWM
• UDI-Device Identifier: 10381780520412
• UDI-Public: 10381780520412
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: 826631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown