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

Model Number	82-6638
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	10/19/2022
Type of Reportable Event	Serious Injury
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
A facility reported that a microsensor kit w/ skull bolt (id 826638) was implanted on (b)(6) 2022.After installing the sensor, the monitor displayed "-99", making it impossible to measure accurately.The microsensor was removed, and another product was used and completed.It is unknown which monitor and cable were used.It is unknown if the event lead to an increase in surgery time; however, no patient injury or death occurred.
Additional Manufacturer Narrative
The microsensor (id 826638) was returned for evaluation.Device history record (dhr) - lot 3943861 (sn (b)(6)) met specifications when released.Failure analysis: the issue of the complaint was not confirmed.No visible damage to the millar sensor, catheter material, or connector.The icp express read 500.The device passed electronic, noise, linearity/hysteresis and signal drift tests.The root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause pf the issue reported by customer could probably be due to an incorrect set-up of device.
Event or Problem Description
N/a.

• Brand Name: MICROSENSOR KIT W/ SKULL BOLT
• Common Device Name: ICP MICROSENSORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15858614
• Report Number: 3013886523-2022-00550
• Device Sequence Number: 20558178
• Product Code: GWM
• UDI-Device Identifier: 20886704042386
• UDI-Public: 20886704042386
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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 Expiration Date: 06/30/2024
• Device Model Number: 82-6638
• 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): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2019
• 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