MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICROSENSOR KIT W/ SKULL BOLT; ICP MICROSENSORS

Catalog Number	826638
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that a few days after a microsensor (id 826638) implantation, the connected icp express started showing negative values such as -50mmhg/ -90mmhg etc.According to information provided, the product ids for the monitor and cable used were unknown.It is also unknown when was the implantation and explant date.It is unknown if the patient had any signs and symptoms due to negative values.
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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The microsensor (id 826638) was returned for evaluation.Device history record (dhr) - the product code 826638 with lot # 6773933, sn # (b)(6), conformed to the specifications when released to stock.Failure analysis - no visible damage to the sensor, catheter material or connector.Icp express read 516.The device passed electronic, noise, linearity/hysteresis and signal drift tests.The complaint was not confirmed.Root cause analysis - the possible root cause for this issue reported by the customer could be due to an unstable sensor performance or incorrect selection of semiconductor components.

• Brand Name: MICROSENSOR KIT W/ SKULL BOLT
• Common Device Name: ICP MICROSENSORS
• 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: 19054536
• Report Number: 3013886523-2024-00104
• Device Sequence Number: 18172924
• Product Code: GWM
• UDI-Device Identifier: 10381780520504
• UDI-Public: (01)10381780520504(17)270930(10)6773933
• 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): 01/22/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 826638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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
• Patient Sex: Unknown