MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACCURIAN; GENERATOR, LESION, RADIOFREQUENCY

Model Number	AG1000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
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 healthcare provider (hcp) via a manufacturer representative (rep) regarding a radio frequency ablation (rfa) device.It was reported that on (b)(6) 2020, while doing a lesion on a patient with "dry scaly" skin, the generator displayed a code of f07.The hcp used another generator, and the same code appeared when they began to do a lesion.They then had to finish the lesion using a competitor's generator.When they took the grounding pad off of the patient, they noticed there was a lot of dead/dry tissue on the grounding pad.It was noted that two additional cases took place after this patient, and the f07 code did not appear during those two cases.Technical services reviewed that the f07 code could indicate an open circuit due to the tissue blocking the current from circulating, and reviewed repositioning the cannula/needle could have been tried.Additional information was received from a manufacturer representative (rep).It was clarified that the original generator was used on the following two cases, and a new grounding pad was used each time.It was reported that the generators would not be returned for analysis as the hcp did not want to have them returned.No further symptoms or complications are anticipated.

• Brand Name: ACCURIAN
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10362223
• Report Number: 2182207-2020-00640
• Device Sequence Number: 3004776
• Product Code: GXD
• UDI-Device Identifier: 00763000140809
• UDI-Public: 00763000140809
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 08/04/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AG1000
• Device Catalogue Number: AG1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1