MAUDE Adverse Event Report: SPINESMITH HOLDINGS,LLC ARVATI; RF GENERATOR

Model Number	G2
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician reported that her last two patients reported multiple shock sensation during their thermiva treatments.Investigation noted that the physician was using rfde-va-g2 lot# l18e027 and grounding pad cat: #2130aclot# 20160720 expired as of 07/19/2018.As a courtesy, the physician was sent replacement electrodes and grounding pads and informed that use of expired grounding pads is not acceptable.Complaint was closed 07/27/21.During 2023 fda audit, inspector indicated that the complaint required re-assessment.Complaint was re-opened on 08/04/23.Review of the customer website notes that the office is still providing thermiva procedures.
Additional Manufacturer Narrative
Arvati device was not returned for evaluation because during complaint call it was noted that the physician was using expired grounding pads.The grounding pads were discarded by the user.
Additional Manufacturer Narrative
Arvati device was not returned for evaluation because during complaint call it was noted that the physician was using expired grounding pads.The grounding pads wwere discarded by the user.Update: udi related data quality update.
Event or Problem Description
Physician reported that her last two patients reported multiple shock sensation during their thermiva treatments.Investigation noted that the physician was using rfde-va-g2 lot# l18e027 and grounding pad cat: #2130aclot# 20160720 expired as of 07/19/2018.As a courtesy, the physician was sent replacement electrodes and grounding pads and informed that use of expired grounding pads is not acceptable.Complaint was closed 07/27/21.During 2023 fda audit, inspector indicated that the complaint required re-assessment.Complaint was re-opened on 08/04/23.Attempts have been made on 08/08/23 (voicemail left), 08/18/23 (email) and 08/22/23 (email).No response as of 11/19/23.Review of the customer website notes that the office is still providing thermiva procedures.Additional follow up email requesting status ot thermiva procedure sent to physician on 11/16/23 by current spinesmith quality manager.

• Brand Name: ARVATI
• Common Device Name: RF GENERATOR
• Manufacturer (Section D): SPINESMITH HOLDINGS,LLC; 4719 south congress ave; austin TX 78745
• Manufacturer Contact: chriselda martinez ; 4719 south congress ave; austin, TX 78745 ; 5126376745
• MDR Report Key: 18167243
• Report Number: 3006404071-2023-00004
• Device Sequence Number: 17945899
• Product Code: DWG
• UDI-Device Identifier: 00817771029068
• UDI-Public: 00817771029068
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2023

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: G2
• Device Catalogue Number: T50RF
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 11/19/2023
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: #2130 GROUNDING PAD EXP 07/19/18; #2130 GROUNDING PAD EXP 07/19/18; RFDE-VA-G2 ELECTRODE; RFDE-VA-G2 ELECTRODE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female