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

Model Number	82-6631
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
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 a neuromonitor basic kit (id 826631) was placed on (b)(6) 2022.After the patient was sent back to ward the microsensor could not show a normal readings.They changed with a new icp monitor (id 826635) and new cable however, the microsensor still could not show normal reading with p-0 on the monitor and could not enter into the next step.Therefore, the microsensor was removed on (b)(6) 2022 and monitoring was stopped.
Additional Manufacturer Narrative
The microsensor was returned for evaluation.Device history record (dhr) - the product 826631 for lot 218153 sn (b)(6) and the lot met specifications when released.Failure analysis - the he issue of the complaint has been confirmed.Connector wire broken inside.Excessive amount of foreign residue covering inside of connector.No testing was possible.The root cause could be determined as a mishandling of the device.Suspect fluid ingress the cause of the foreign residue inside of connector.

• 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: 15001104
• Report Number: 3013886523-2022-00322
• Device Sequence Number: 1614236
• 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
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 82-6631
• Device Catalogue Number: 826631
• Device Lot Number: 218153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2018
• 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