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

Model Number STIMULUS ELECTRODE

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2020

Event Type  malfunction  

Manufacturer Narrative

Hospital's risk management reported the treating electrode "popped off" the patient's right temple.After the electrode came loose, they checked the patient, wiped off a black mark and they determined that there was no burn or injury to the patient.This is stated in their report.They did not return the specific electrode, or any others from that batch or provide the lot number.There were no other reports by this hospital or by any other medical facility concerning electrodes popping off.The instruction for use are included with every box of electrodes, so it is believed these instructions were not followed.Since there was no injury to the patient, and no return of any electrodes by the hospital, somatics considers this report to be finalized.

Event Description

During treatment a stimulus electrode came loose from the patient.There was no injury to the patient reported.

• Brand Name: THYMAPAD
• Type of Device: STIMULUS ELECTRODE
• Manufacturer (Section D): SOMATICS, LLC; 720 commerce drive; suite 101; venice, fl
• Manufacturer (Section G): SOMATICS, LLC; 720 commerce drive; suite 101; venice, fl
• Manufacturer Contact: david mirkovich ; 720 commerce drive; suite 101; venice, fl ; 2346761
• MDR Report Key: 9889266
• MDR Text Key: 186901805
• Report Number: 1420295-2020-00004
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 882809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/24/2020

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
• Device Operator: No Information
• Device Model Number: STIMULUS ELECTRODE
• Device Catalogue Number: EPAD
• Device Lot Number: N / A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 3901330000-2020-8006
• Patient Sequence Number: 1
• Patient Age: 95 YR