CYMEDICA ORTHOPEDICS QB1 NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM

Additional Manufacturer Narrative

COMPLAINT FAILURE WAS NOT ABLE TO BE RECREATED - COMPLAINT UNIT WAS NOT RETURNED TO CYMEDICA FOR FURTHER INVESTIGATION. PER CUSTOMER SERVICE, REPLACEMENT ELECTRODES WERE SENT TO CUSTOMER FOR REPLACEMENT OF OLD ELECTRODES FROM COMPLAINT UNIT. PER E-MAIL COMMUNICATION, PATIENT USED SAME SET OF ELECTRODES SINCE LATE AUGUST 08/2020 WITHOUT APPLICATION OF ELECTRODE GEL. IMAGES OF ELECTRODES SUPPLIED BY CUSTOMER EXHIBITED WORN HYDROGEL SURFACE. EDGES OF HYDROGEL LAYER FOUND PEELING AWAY/MISSING AT ELECTRODE EDGES. WORN/DRY ELECTRODES RESULT IN POOR CONDUCTION REQUIRING HIGHER LEVELS OF STIMULATION WITH POTENTIAL OF DISCOMFORT AND BURNING. DRY ELECTRODES ARE TO BE REPLACED WITH FRESH ELECTRODES. CS COMMUNICATION WITH CUSTOMER EMPHASIZED NEED TO CLEAN ELECTRODES, UTILIZE COVERS POST-USE TO RETAIN HYDROGEL SURFACE MOISTURE/CLEANLINESS, AND APPLICATION OF ELECTRODE GEL TO AID ELECTRODE CONDUCTION AND MOISTURE.

Description of Event or Problem

ON OCTOBER 29, 2020 PATIENT CONTACTED CYMEDICA CUSTOMER SERVICE REGARDING BURNS HE RECEIVED FROM THE ELECTRODES. THE "BURN" MARKS ARE HEALED NOW; PLEASE TAKE NOTE THAT HE USED THE SAME SET OF PADS SINCE LATE AUGUST. THE PATIENT DID NOT USE GEL. CUSTOMER SERVICE SHIPPED HIM NEW ELECTRODES AND RE-EDUCATED HIM ON USE/CARE ETC.