MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ACCURIAN; GENERATOR, LESION, RADIOFREQUENCY

Model Number	AG1000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative (rep) via the healthcare professional (hcp) regarding a radio frequency ablation (rfa) system.The rep is in the middle of a case and they are getting code f07.The grounding pad is securely in the left flank and has good contact.The rep confirmed that they followed proper troubleshooting guidance and rebooted the system prior to calling technical services.They only get the f07 code when they activate motor or sensory testing.The rep confirmed that every probe is connected and within temperature.Technical services reviewed retrieving a second grounding pad to see if that resolves the code.The managing physician indicated that it did not resolve the code.The hcp¿s major complaint is that there is no way of knowing the system is going to fall until they are in the middle of the case and that is a risk to the patient.Technical services transferred the rep to have the system replaced.The caller confirmed that the patient is getting taken out of the operating room (or) and they plan to reschedule the procedure.The symptoms reported were patient discomfort.The rma number is (b)(4).No further complications were reported/are anticipated.
Additional Manufacturer Narrative
Analysis found no device problem.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACCURIAN
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 9047725
• Report Number: 1030489-2019-01022
• Device Sequence Number: 14082511
• Product Code: GXD
• UDI-Device Identifier: 00763000140809
• UDI-Public: 00763000140809
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181864
• 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): 01/21/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AG1000
• Device Catalogue Number: AG1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 01/21/2020
• 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