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

Model Number	82-6631
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that after the neuromonitor basic kit (id 826631) was implanted, the icp did not show the icp readings.The icp monitor used was icp express, 220 volt (id 826635).The issue was detected before the site closure and the event led to 10 minutes surgical delay.The reported microsensor was changed to a new one.The patient status was stable.
Additional Manufacturer Narrative
The neuromonitor basic kit (id 826631) was not returned for evaluation (discarded) therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) 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: 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: 12830470
• Report Number: 3013886523-2021-00506
• Device Sequence Number: 1520604
• Product Code: GWM
• UDI-Device Identifier: 20886704042317
• UDI-Public: (01)20886704042317(17)240930(10)4154803
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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: 09/30/2024
• Device Model Number: 82-6631
• Device Catalogue Number: 826631
• Device Lot Number: 4154803
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/17/2021
• Date Device Manufactured: 10/30/2019
• 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