RS 4I PLUS

Description of Event or Problem

PATIENT INDICATED HIS DEVICE BURNED HIM ON (B)(6). THE LAST TREATMENT PATIENT TOOK WAS (B)(6). PATIENT STATED HE HAS TAKEN 10 TREATMENTS. THE FIRST 9 TREATMENTS HE KEPT THE INTENSITY LEVEL AT A COMFORTABLE LEVEL. PATIENT INDICATED THE INTENSITY LEVELS WERE AT " SOMEWHERE IN THE LOWER OR A LITTLE BIT BETWEEN THE MIDDLE. IT WASN'T REALLY HIGH". PATIENT STATED THE 10TH TREATMENT FELT MORE INTENSE AND HE TOOK THE TREATMENT LAYING DOWN ON HIS BACK. PATIENT STATED ON HIS 10TH TREATMENT HE TURNED UP THE INTENSITY MORE THAN THE 9 OTHER TREATMENTS AS HE FELT HE COULD TOLERATE IT. PATIENT STATED HE NOTICED IT WAS QUITE PAINFUL TAKING OFF THE PADS FROM HIS LAST TREATMENT. HE STATED THE PADS BURNED HIM AND HE STILL HAS A SCAR. PATIENT STATED HE DOES NOT USE ANY LOTIONS OR OILS AND TOOK TREATMENT WITH CLEAN DRY SKIN. PATIENT HAS NOT CHANGED PADS SINCE GETTING THE DEVICE. PATIENT HAS ONLY USED THE LOW BACK GARMENT. PATIENT STATED HE HAS MISSED ALMOST 3 WEEKS OF WORK DUE TO THE BURNS AND HE WENT TO THE ER. PATIENT INDICATED HIS DOCTOR ADVISED HE NOT CONTINUE USE AND HE DOES NOT WANT TO USE THE DEVICE. WE OFFERED TO MAIL RETURN MATERIALS BUT PATIENT STATED HE WANTED TO HOLD OFF ON RETURNING THE DEVICE. PATIENT STATED HE HAS PICTURES OF THE BURNS AND WILL EMAIL THEM TO CUSTOMER SERVICE. PATIENT STATED HE WOULD LIKE TO BE COMPENSATED FOR HIS PAIN AND SUFFERING AND SINCE HE HAD TO MISS 3 WEEKS OF WORK. PATIENT HAS BEEN VERY HARD TO REACH AND NON-COMMUNICATIVE. ALTHOUGH THE DATE OF OCCURRENCE WAS (B)(6) 2025, THE INCIDENT AWARE DATE WAS 9/22/25. PATIENT HAS 2 RS-4I PLUS DEVICES. SERIAL NUMBER (B)(6) FROM (B)(6) 2017 AND SERIAL NUMBER (B)(6) FROM (B)(6) 2025. THE DEVICE LISTED ON THE COMPLAINT IS THE DEVICE FROM 2017 AND WE SUSPECT IT IS ACTUALLY THE DEVICE FROM 2025 SINCE HE SAID HE HAD ONLY USED IT 10 TIMES. WE CAN'T CONFIRM THIS AS THE PATIENT WILL NOT RETURN CALLS. THE PATIENT ALSO DOES NOT WANT TO RETURN THE DEVICE FOR INVESTIGATION. WE WILL CONTINUE TO FOLLOW UP WITH THE PATIENT AND REQUEST THE RETURN OF THE DEVICE SO THAT WE CAN COMPLETE AN ENGINEERING INVESTIGATION OF THE RS 4I PLUS DEVICE AND GARMENT. UPON SUCCESS, WE WILL FILE AND ADDENDUM TO THIS MDR WITH THE FDA.

Additional Manufacturer Narrative

PATIENT DOES NOT WANT TO RETURN DEVICE SO WE ARE STILL WAITING ON THE RETURN OF THE STIMULATION SYSTEM AND LOW BACK GARMENT/ELECTRODES FOR TESTING AND EVALUATION.