MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR NEUROMONITOR BASIC KIT; ICP MICROSENSORS

Model Number	826631
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that when the operator opened the microsensor ((b)(4)) and connected it to the main unit during the surgery, it was not recognized.The procedure was completed with a replacement product available.The issue was detected before the implantation site closure.No surgical delay or adverse consequences to the patient were observed.
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
The microsensor (id: 826631) 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(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to excessive pressure applied to product.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
The microsensor (id 826631) was returned for evaluation.Device history record (dhr) - for lot 3974832 (sn (b)(6)), and the lot 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.Cerelink monitor reading was acceptable; icp express passed with reading 491.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 of the defect reported by the customer could be due to excessive pressure applied to product.

• Brand Name: NEUROMONITOR BASIC KIT
• 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: 13542728
• Report Number: 3013886523-2022-00052
• Device Sequence Number: 17184151
• Product Code: GWM
• UDI-Device Identifier: 20886704042317
• UDI-Public: 20886704042317
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 826631
• Device Catalogue Number: 826631
• Device Lot Number: 3974832
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 04/26/2022; 10/04/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 05/07/2022; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2019
• 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