MAUDE Adverse Event Report: SOMATICS, LLC THYMAPAD STIMULUS ELECTRODE; EPAD

Lot Number 033649

Device Problems Smoking (1585); Sparking (2595)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

Somatics received the paper medwatch report, mw5106067 late on januray 25, 2022.Several telephone calls were placed to the initial reporter with no answer.An e-mail was sent as follow up.The initial reporter did call back and a brief telephone conversation followed.She said condition of the patient or the report from the er after the incident was not available.The hospital's risk and legal departments told her not to answer those questions plus almost all the other questions.She did say that the thymapad in question was kept by the hospital but would not be made available to somatics to investigate.The name of the hospital was not allowed to be given.She did state that other thymapads from the same lot number had been used by her hospital prior to this incident with no problems.Since no information about the patient's exact injury or outcome, no hospital name and no other information was allowed to be given to somatics, the call was ended.Based on the stated use of the same lot number with no problems by this hospital and no other reports from any other user with this same lot number, 033649, somatics can only conclude this was an isolated occurrence.The most probable cause was that the thymapad had dried out due to age, or that it had been placed over the patient's hair, thus making poor contact with the patient.Once again, wihout any additional information from the initial reporter, the investigation could not proceed.Since (b)(4) electrodes had been sold with no other reports of any problems, somatics used the probable cause mentioned above.Because somatics is unable to obtain any additional information based upon the hospital's risk & legal departments, we cannot conclude the thymapad in question malfunctioned.It might have been at fault or it could have been a user's error.Once again, there were no other problems with the other 99,999 electrodes.We are submitting this report to the fda in abundance of caution and to ensure full compliance with 21 cfr part 803.

Event Description

As reported on the medwatch form, mw5106067, during an ect treatment the electrode sparked and there was smoke.Slight burn noted on patient skin.Patient was sent to er for observation.There was no further input on ther patient's status.

• Brand Name: THYMAPAD STIMULUS ELECTRODE
• Type of Device: EPAD
• Manufacturer (Section D): SOMATICS, LLC; 720 commerce drive; suite 101; venice FL 34292
• Manufacturer (Section G): SOMATICS, LLC; 720 commerce drive; suite 101; venice FL 34292
• Manufacturer Contact: david mirkovich ; 720 commerce drive; suite 101; venice, FL 34292
• MDR Report Key: 13599466
• MDR Text Key: 289102659
• Report Number: 1420295-2022-00001
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 882809A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2022

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
• Device Lot Number: 033649
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1