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

Model Number	82-6631
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/12/2021
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 microsensor was implanted on (b)(6) 2021, three days later it could not be detected and was explanted on (b)(6) 2021.Patient is in stable condition.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The microsensor (b)(4) was returned for evaluation.Failure analysis - received catheter in a drainage tube.Debris covering sensor area and suture right below sensor.Sensor diaphragm is broken.Icp express read no transducer detected.No testing was possible.The issue of the complaint has been confirmed.The possible root cause of the defective device could be due to mishandling of the catheter.

• 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: 13228993
• Report Number: 3013886523-2021-00594
• Device Sequence Number: 19874881
• 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: 2021
• Device Explanted Year: 2021
• 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): 03/30/2022

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 Model Number: 82-6631
• Device Catalogue Number: 826631
• Device Lot Number: 3963073
• 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: 12/26/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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