THERMIVA
Report
- Report Number
- 3006404071-2024-00006
- Event Type
- Injury
- Date Received
- August 21, 2024
- Date of Event
- June 24, 2024
- Report Date
- August 16, 2024
- Manufacturer
- SPINESMITH HOLDINGS,LLC
- Product Code
- DWG
- PMA / PMN Number
- K130689
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MORE DETAILS TO FOLLOW ONCE INVESTIGATION AND ROOT CAUSE ANALYSIS DETAILS ARE OBTAINED FROM THE SME AND CUSTOMER. UPDATE: SEE B5 OF THIS SUBMISSION.
MORE DETAILS TO FOLLOW ONCE INVESTIGATION AND ROOT CAUSE ANALYSIS DETAILS ARE OBTAINED FROM THE SME AND CUSTOMER.
CUSTOMER UNIT SHOWED UP, WITHOUT A RMA ON (B)(6) 2024. SERVICE, CUSTOMER SERVICE AND TECHNICAL SUPPORT HAD TO INVESTIGATE WHERE THE UNIT CAME FROM. ON (B)(6) 2024, CUSTOMER REPRESENTATIVE REPORTED THAT THE CUSTOMER REPORTS A BURN HAPPENED DURING THE THERMIVA PROCEDURE USING THEIR THERMIVA GENERATOR. INVESITIGATION NOTED THAT THIS CUSTOMER IS ALREADY BEING MANAGED UNDER A PRIOR CUSTOMER FEEDBACK CASE (B)(4) WHICH IS STILL OPEN. CUSTOMER REPORTED HI IMPEDANCE ON THEIR THERMIVA. THE CUSTOMER WAS SENT A LOANER DEVICE WHILE THEIR DEVICE WAS BEING EVALUATED. INVESTIGATION NOTES THAT THE CUSTOMER DEVICE WOULD TAKE SOME TIME TO ADDRESS AND IT WAS DECIDED TO SEND THE CUSTOMER A REPLACEMENT DEVICE. CUSTOMER RECEIVED THIS DEVICE AND WAS SATISFIED. CUSTOMER REPRESENTATIVE INFORMED TECHNICAL SUPPORT THAT THE CUSTOMER REPORTED THAT A PATIENT REPORTED THAT THEY HAD A BURN ON THEIR THIGH WHERE THE GROUNDING PAD WAS PLACED AFTER THE PROCEDURE WAS DONE. THE PATIENTS SPOUSE IS A DR AND THEY ARE TREATING THE BURN AT HOME, HOWEVER PATIENT WOULD LIKE TO CONTINUE THEIR TREATMENT AS SCHEDULED. SME IS ATTEMPTING TO REACH OUT TO THE CUSTOMER TO GATHER MORE PROCEDURAL DETAILS IN ORDER TO DETERMINE ROOT CAUSE. CUSTOMER DID REPORT THAT THEY HAD THROWN AWAY THE GROUNDING PADS AND ELECTRODES USED DURING THE PROCEDURE. TECHNICAL SUPPORT IIS WORKING ON SENDING A REPLACEMENT VA UNIT. MORE DETAILS WILL BE REPORTED ONCE THE SME HAS CONVERSED WITH THE DRS OFFICE. UPDATE: FINAL CF DISPOSITION REPORT: CUSTOMER REPRESENTATIVE INFORMED TECHNICAL SUPPORT THAT THEIR CUSTOMER - (B)(6) CLINIC - HAS INDICATED THAT THERE WAS AN INCIDENT WITH A BURN. CUSTOMER WAS UNABLE TO PROVIDE MORE DETAILS AS THE INDIVIDUAL WHO WAS INVOLVED WAS NOT AVAILABLE AT THE TIME. TECHNICAL SUPPORT CONTACTED THE CUSTOMER ON (B)(6) 2024 AND THE INDIVIDUAL WAS STILL NOT AVAILABLE. THE CUSTOMER NOTED THAT THEY WOULD RETURN ON (B)(6) 2024. CUSTOMER CONTACTED TECHNICAL SUPPORT ON (B)(6) 2024 WITH THE FOLLOWING DETAILS: CUSTOMER - (B)(6) CLINIC - REPORTED THAT CUSTOMER NOTIFIED THEM THAT THEY NOTICED A BURN ON THEIR RIGHT THIGH AFTER THEIR THERMIVA TREATMENT. THERMIVA GENERATOR GEN 1 SN# (B)(6). CUSTOMER DID MENTION THAT THE PATIENT DID SAY THEY FELT HEAT AT THE SITE OF THE GROUNDING PAD HOWEVER NOT ENOUGH TO STOP THE TREATMENT. THE CUSTOMER INFORMED TECHNICAL SUPPORT THAT THE PATIENT WAS DOING THEIR OWN TREATMENT ON THE BURN AS THEIR HUSBAND WAS A DOCTOR. THE PATIENT IS A FREQUENT CLIENT AND DOES PLAN ON RETURNING FOR FURTHER TREATMENTS. TECHNICAL SUPPORT ASKED ADDITIONAL PROCEDURE QUESTIONS: 1. WAS THE GROUNDING PAD, THERMI BRANDED? 2. WAS THE GROUNDING PAD EXPIRED? 3. WHERE WAS THE GROUNDING PAD PLACED ON THE THIGH? 4. HOW WAS THE AREA PREPPED? 5. WAS THE PATIENT HOLDING A CELL PHONE OR OTHER ELECTRONIC DEVICE OR TUCKED UNDER WHERE THE GROUNDING PAD WAS PLACED? THE CUSTOMER STATED THEY WERE UNSURE OF THE BRANDING OR EXPIRATION DATE, AS THE GROUNDING PAD WAS DISCARDED, AND THEY WERE OUT. THE CUSTOMER ALSO STATED THAT THEY NEEDED TO SPEAK WITH THEIR OFFICE MANAGER AND GET BACK TO US ON THE OTHER QUESTIONS. CUSTOMER DID REQUEST A LOANER. (B)(6) APPROVED THE LOANER AND CALLING SERVICE PERSONNEL TESTED THE LOANER THERMIVA DEVICE SN#(B)(6) PRIOR TO SENDING TO THE CUSTOMER TO ENSURE THE DEVICE WAS TESTING WITHIN EXPECTED RELEASE SPECIFICATIONS. TESTING WAS COMPLETED IN ACCORDANCE WITH (B)(4) THERMI REVS TESTING FORM. ALL RESULTS TESTED WITHIN EXPECTED SPECIFICATIONS. ALTHOUGH VERIFICATION OF FAILURE TO THE GROUNDING PAD COULD NOT BE CONCLUDED (USED GROUNDING PAD WAS DISCARDED BY THE CUSTOMER), A REPLACEMENT GROUNDING PAD WAS SENT AS A COURTESY ALONG WITH THE REQUESTED LOANER THERMIVA. THE CUSTOMER ALSO STATED THEY HAD PICTURES OF THE BURN, BUT THE OFFICE COULD NOT PROVIDE THESE TO CALLING CITING PATIENT PRIVACY LAW. FIELD SME, (B)(6) ATTEMPTED TO CONTACT THE CUSTOMER FOR MORE INFORMATION AND PROVIDE GUIDANCE, HOWEVER, WAS UNSUCCESSFUL. (B)(6) LEFT WEEKLY MESSAGES AT THEIR MAIN OFFICE NUMBER AND CELL NUMBER PROVIDED BY THE CALLER BUT RECEIVED NO RESPONSES. AS OF (B)(6)2024, SME HAS NOT BEEN ABLE TO CONNECT WITH THE CUSTOMER. REVIEW OF THE CUSTOMER ACCOUNT SHOWS THAT THEY HAVE CONTINUED TO PURCHASE RFDE-VA ELECTRODES INDICATING THEY HAVE CONTINUED TO PERFORM VA PROCEDURES. THE MOST RECENT SALES TRANSACTIONS OCCURRED ON (B)(6)2024. DURING THIS INVESTIGATION THE CUSTOMER DID RETURN AN EXTRA LOANER THERMIVA DEVICE THEY HAD AS THEY DID NOT NEED IT. SN#(B)(6) WAS RECEIVED AND TESTED IN ACCORDANCE WITH (B)(4) THERMI REVS TESTING FORM. ALL RESULTS TESTED WITHIN EXPECTED SPECIFICATIONS. QUALITY COMPLETED (B)(4) ADVERSE EVENT DETERMINATION FORM. BASED ON THE INFORMATION CURRENTLY COLLECTED OF A BURN TO THE PATIENT, IT WAS INDICATED THAT IT DID NOT RESULT IN A SERIOUS INJURY OR DEATH, A 5-DAY REPORT WAS NOT REQUIRED AND REPORT TO EMDR SHALL BE MADE WITHIN A 30-DAY WINDOW OF CONFIRMATION OF BURN AND DETAILS. INITIAL EMDR WAS SUBMITTED ON (B)(6)2024 EMDR# 30006404071-2024-00006. THE EMDR WAS MADE BASED ON THE INFORMATION COLLECTED FROM THE CUSTOMER ON (B)(6)2024. FOLLOW UP EMDR# 30006404071-2024-00006 (#001) WAS SUBMITTED ON (B)(6)2025. AN ADDITIONAL REVIEW OF THE CUSTOMER ACCOUNT SHOWED THAT THE CUSTOMER CONTINUES TO MAKE PURCHASES FOR RFDE-VA ELECTRODES. THE MOST RECENT SALES TRANSACTIONS OCCURRED ON (B)(6)2025. BASED ON THE RESULTS OF THE TESTING OF THE CUSTOMERS DEVICES SN#(B)(6). THERE IS NO INDICATION THAT THE CULPRIT OF THE ADVERSE EVENT WAS THE THERMI DEVICE AND IN FACT MAY HAVE BEEN A USER ERROR. CUSTOMER ACCOUNT WILL CONTINUE TO BE MONITORED FOR ADDITIONAL INCIDENTS. CF CLOSED.
CUSTOMER UNIT SHOWED UP , WITHOUT A RMA ON 06/24/24. SERVICE, CUSTOMER SERVICE AND TECHNICAL SUPPORT HAD TO INVESTIGATE WHERE THE UNIT CAME FROM. ON 07/01/24, CUSTOMER REPRESENTATIVE REPORTED THAT THE CUSTOMER REPORTS A BURN HAPPENED DURING THE THERMIVA PROCEDURE USING THEIR THERMIVA GENERATOR. INVESTIGATION NOTED THAT THIS CUSTOMER IS ALREADY BEING MANAGED UNDER A PRIOR CUSTOMER FEEDBACK CASE (B)(4) (CASE# (B)(4)) WHICH IS STILL OPEN. CUSTOMER REPORTED HI IMEPDANCE ON THEIR THERMIVA. THE CUSTOMER WAS SENT A LOANER DEVICE WHILE THEIR DEVICE WAS BEING EVALUATED. INVESTIGATION NOTES THAT THE CUSTOMER DEVICE WOULD TAKE SOME TIME TO ADDRESS AND IT WAS DECIDED TO SEND THE CUSTOMER A REPLACEMENT DEVICE. CUSTOMER RECEIVED THIS DEVICE AND WAS SATISFIED. CUSTOMER REPRESENTATIVE INFORMED TECHNICAL SUPPORT THAT THE CUSTOMER REPORTED THAT A PATIENT REPORTED THAT THEY HAD A BURN ON THEIR THIGH WHERE THE GROUNDING PAD WAS PLACED AFTER THE PROCEDURE WAS DONE. THE PATIENTS SPOUSE IS A DR AND THEY ARE TREATING THE BURN AT HOME, HOWEVER PATIENT WOULD LIKE TO CONTINUE THEIR TREATMENT AS SCHEDULED. SME IS ATTEMPTING TO REACH OUT TO THE CUSTOMER TO GATHER MORE PROCEDURAL DETAILS IN ORDER TO DETERMINE ROOT CAUSE. CUSTOMER DID REPORT THAT THEY HAD THROWN AWAY THE GROUNDING PADS AND ELECTRODES USED DURING THE PROCEDURE. TECHNICAL SUPPORT IIS WORKING ON SENDING A REPLACEMENT VA UNIT. MORE DETAILS WILL BE REPORTED ONCE THE SME HAS CONVERSED WITH THE DRS OFFICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1045177 | THERMIVA | THERMIVA | DWG | SPINESMITH HOLDINGS,LLC | THERMIVA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other | GROUNDING PAD #2130AC.| GROUNDING PAD #2130AC. |