MAUDE Adverse Event Report: RENISHAW MAYFIELD NEUROMATE GEN III STEREOTACTIC SYSTEM

Model Number	NEUROMATE V1.5
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This issue occurred in bordeaux, france, but is being documented as a precautionary measure because it involves a device that has been cleared in the us and meets the reporting requirements according to cfr 803.50 (2).During a dbs surgery, an inaccuracy in the placement of the electrode was observed.The electrode was delivered using the neuromate system.The inaccuracy observed exceeded the specifications of the neuromate system set by the manufacturer.At this time it has not been concluded if a device malfuction was the cause of the inaccuracy.The possible impact of this inaccuracy is that it could cause damage if unintended structures are passed through, and the dbs leads might be placed in the incorrect part of the brain.Although it is unlikely that this issue could result in death or serious injury, there is a potential for such an outcome in the worst-case scenario.
Additional Manufacturer Narrative
A number of root causes were identified as part of the capa investigation not all of these are due to the neuromate system.It was found that the hospital was mishandling the neuromate system by moving it around using the frame support, other general mishandling during transfer from operating room to storage location (and visa versa) was also adding to the overall issue.This was resulting in the system being moved out of calibration over time and impacting the accuracy seen.There is a diagnostic check which can be completed prior to the patient entering the operating room to ensure that the system is still within calibration.This was not routinely carried out at the hospital.There are also third party devices which are being used with the system which are contributing to the inaccuracies seen.The leksell fiducial tools used in the workflow were incorrectly installed.It was observed that the electrode did not remain in the exact same trajectory as the guide cannula it was delivered through, once the cannula was removed.This may be due to the flexibility and length of the electrode used.There is not one issue which caused the inaccuracy seen, which was within the specification for the neuromate system.The drift of the calibration of the neuromate system added to the use of the third party elements resulted in the inaccuracies seen.
Event or Problem Description
This issue occurred in (b)(6) france, but is being documented as a precautionary measure because it involves a device that has been cleared in the us and meets the reporting requirements according to cfr 803.50 (2).During a dbs surgery, an inaccuracy in the placement of the electrode was observed.The electrode was delivered using the neuromate system.The inaccuracy observed exceeded the specifications of the neuromate system set by the manufacturer.At this time it has not been concluded if a device malfunction was the cause of the inaccuracy.The potential impact of inaccuracy, if it were to occur again, is that it could cause damage if unintended structures are passed through, and the dbs leads might be placed in the incorrect part of the brain.Although it is unlikely that this issue could result in death or serious injury, if it were to occur again, there is a potential for such an outcome in the worst-case scenario.

• Brand Name: NEUROMATE GEN III STEREOTACTIC SYSTEM
• Common Device Name: NEUROMATE GEN III
• Manufacturer (Section D): RENISHAW MAYFIELD; 31 rue ampere; chassieu; chassieu, 69680 ; FR 69680
• Manufacturer (Section G): RENISHAW MAYFIELD SARL; 31 rue ampere, ,; chassieu, 69680 ; FR 69680
• Manufacturer Contact: ruth rusling ; 31 rue ampere, ,; chassieu, 69680 ; FR 69680
• MDR Report Key: 20742647
• Report Number: 3009108888-2024-00001
• Device Sequence Number: 18331715
• Product Code: HAW
• UDI-Device Identifier: 03662724000345
• UDI-Public: 03662724000345
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NEUROMATE V1.5
• Device Catalogue Number: 001.0050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown