MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA COMPLETE BRAIN IMC PROBE KIT; N/A

Model Number	IP2P
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that the complete brain probe (p2peu) did not pass the patient's dura mater but "push it forward." the issue led to an air collection between the skull and dura (the probe seemed to have pushed the dura forward instead of passing through it).There was no bleeding or contusions and the air collection had almost fully resolved (as checked on ct scan of the brain) once the bolt/probe was removed and a new one placed on the contralateral side.A single lumen bolt and icp probe from camino was used to complete the procedure.There was no further patient consequence.
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
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 the complete brain probe (p2peu) did not pass the patient's dura mater but "push it forward." the issue led to an air collection between the skull and dura (the probe seemed to have pushed the dura forward instead of passing through it).There was no bleeding or contusions and the air collection had almost fully resolved (as checked on ct scan of the brain) once the bolt/probe was removed and a new one placed on the contralateral side.A single lumen bolt and icp probe from camino was used to complete the procedure.There was no further patient consequence.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Complete brain probe (p2peu) was not returned for evaluation after three good faith attempts (gfes) were made, thus the complaint is considered unverifiable.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.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: COMPLETE BRAIN IMC PROBE KIT
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13443690
• Report Number: 9612007-2022-00003
• Device Sequence Number: 17219682
• Product Code: GWM
• UDI-Device Identifier: 10381780250333
• UDI-Public: 10381780250333
• Combination Product (Y/N): N
• PMA/510(K) Number: K040235
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 08/31/2021
• Device Model Number: IP2P
• Device Catalogue Number: IP2PEU
• Device Lot Number: 0220532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/21/2022
• Date Device Manufactured: 08/31/2020
• 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