MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER; LICOX BOLTS CATHETERS & KITS

Catalog Number	IP2P
Medical Device Problem Code	Program or Algorithm Execution Failure (4036)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that they kept getting a smart card error while using the "kit containing cc1.P1 and the ip2 introducer (ip2p)"; therefore, they explanted the sensor and placed it in a biohazard bag.Additional information has been requested.
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The kit containing cc1.P1 and the ip2 introducer (ip2p) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause could not be determined.However, a probable root cause for the reported complaint could be due to human misuse caused by the use of inappropriate card / probe.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h6 (health impact code), h11.Additional information has been received indicating the following: 1.What is the implant/explant date? account never told me an implant date i'm assuming 3/24 because the account got a smart card error on the box and immediately explanted the ip2p probe.2.Was there any patient injury? there was no patient harm.3.Did the patient require further icp monitoring after probe explant? the account never said if additional icp monitoring was required.4.There was no patient harm.
Additional Manufacturer Narrative
The kit containing cc1.P1 and the ip2 (ip2p) introducer was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the device was not returned with the packaging, and the probe was not returned with the protective sheath.The device was investigated visually and under the binocular microscope; no defects were noted.The smart card was tested, and a smart card fault appears on the screen.As a result, no performance test could be carried out with the smart card returned by the customer.A new smart card was re-encoded to perform the test, and the probe passed the test.The problem is linked to the smart card and the issue reported by the customer is confirmed.Root cause - the possible root cause of the customer reported issue could be due to corrupted data on the calibration card or demagnetization of the card.No corrective action is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER
• Common Device Name: LICOX BOLTS CATHETERS & KITS
• 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 08540 ; 6099362319
• MDR Report Key: 19125285
• Report Number: 3013886523-2024-00114
• Device Sequence Number: 7641535
• Product Code: GWM
• UDI-Device Identifier: 10381780250173
• UDI-Public: 10381780250173
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: IP2P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 05/24/2024; 07/23/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 05/02/2024; 06/11/2024; 08/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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
• Patient Age: 40 YR
• Patient Sex: Male