BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARVATI

    MDR report key: 18167243 · Received November 19, 2023

    Report

    Report Number
    3006404071-2023-00004
    Event Type
    Injury
    Date Received
    November 19, 2023
    Date of Event
    March 11, 2021
    Report Date
    November 19, 2023
    Manufacturer
    SPINESMITH HOLDINGS,LLC
    Product Code
    DWG
    UDI-DI
    00817771029068
    PMA / PMN Number
    K130689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925376 ARVATI RF GENERATOR DWG SPINESMITH HOLDINGS,LLC G2 00817771029068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other #2130 GROUNDING PAD EXP 07/19/18| #2130 GROUNDING PAD EXP 07/19/18| RFDE-VA-G2 ELECTRODE| RFDE-VA-G2 ELECTRODE