MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ICP SENSOR CATHETER KIT; ICP MICROSENSORS

Catalog Number	826633
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a microsensor (id 826633) was implanted on (b)(6) 2025.The patient was sent back to the ward after the procedure.The physician tried to reconnect the microsensor, however, the monitor showed an intracranial pressure (icp) reading of 15mmhg to 116mmhg.The patient had a computed tomography (ct) scan without any abnormalities.Due to suspicion of incorrect icp reading the physician retrieved the microsensor and stopped monitoring on the same day.The patient is currently stable and has not experienced any signs or symptoms related to the sensor 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
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The microsensor (id 826633) was returned for evaluation.Device history record (dhr) - was performed on reported lot number 7058645 and no anomalies were identified during the manufacture or packaging of the device.However, the returned device for failure analysis doesn¿t match the reported lot number.Therefore, we have reviewed supplier dhr and kitting dhr for returned device¿s lot number 7058602 and no anomalies were identified during the manufacture or packaging of the device.Failure analysis - since the returned device did not match the reported lot number, the complaint is unconfirmed.Root cause analysis - per the complaint background and during complaint investigation and failure analysis evaluation complaint was not confirmed.
Event or Problem Description
N/a.

• Brand Name: ICP SENSOR CATHETER 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: 21664250
• Report Number: 3014334038-2025-00037
• Device Sequence Number: 7614493
• Product Code: GWM
• UDI-Device Identifier: 10381780520436
• UDI-Public: 10381780520436
• Combination Product (Y/N): N
• PMA/510(K) Number: K991222
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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: 826633
• Device Lot Number: 7058645
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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: CABLE (ID 826636); MONITOR (ID 826635)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian