MAUDE Adverse Event Report: NEUROTHERM, INC SINGLE LESION ET20S¿ PAIN MANAGEMENT RF GENERATOR; ELECTROSURGICAL SPINE GENERATOR

Model Number	NT7209975
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in a subsequent submission.
Event or Problem Description
The generator displayed an error indicating an issue with the probe and the case was abandoned.During a standard radiofrequency procedure for lumbar target, a "fault 06¿ error message occurred multiple times despite cycling the machine and changing out probes.The generator was powered off and on which did not resolve the issue and the case was abandoned.There were no adverse consequences to the patient due to the abandoned procedure.The case was rescheduled and the procedure was completed with a different machine with no consequences.
Additional Manufacturer Narrative
One single lesion et20s¿ pain management rf generator was received for analysis.Ac power was applied to the rf generator which briefly displayed the software version of 2.00 prior to the successful execution of the power on self-test.Default values were then displayed in a numerical format that is consistent with this software version.An unrelated fault 09 was observed prior to functional testing which differs from the fault 06 reported.Note: warning message 09 (body temperature not detected) will be displayed when the measured temperature value is below 33°celsius, to ensure the electrode is properly placed within the anatomy prior to the application of rf energy.This message clears upon acknowledgement and does not prevent device operation.Functional testing confirmed normal impedance and temperature values during the application of rf energy.No warnings, faults, error messages, impedance or temperature fluctuations were observed during the evaluation performed.Based on the information provided to abbott and the investigation performed, the root cause of the field reported event cannot be conclusively determined as the reported issue was unable to be reproduced.

• Brand Name: SINGLE LESION ET20S¿ PAIN MANAGEMENT RF GENERATOR
• Common Device Name: ELECTROSURGICAL SPINE GENERATOR
• Manufacturer (Section D): NEUROTHERM, INC; 600 research drive ste 1; wilmington MA 01887
• MDR Report Key: 8582632
• Report Number: 3002953813-2019-00029
• Device Sequence Number: 3020488
• Product Code: GEI
• UDI-Device Identifier: 05415067022325
• UDI-Public: 05415067022325
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K033981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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: NT7209975
• Device Lot Number: 9800232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other