RS-4I SEQUENTIAL STIMULATOR

Additional Manufacturer Narrative

PATIENT CONTACTED RS MEDICAL BASED ON A CORRECTIVE ACTION CONCERNING THE RS-FBG FULL BACK GARMENT. REPORTED EVENT(S) WERE NOT RELATED TO THE FULL BACK GARMENT AS THAT WAS NOT BEING USED AT THE TIME PER THE PATIENT. PATIENT REPORTED THAT THE STIMULATOR HAS NOT BEEN FUNCTIONING FOR A FEW YEARS (UNRELATED TO THE EVENT REPORT). THE PT WOULD LIKE THE STIMULATOR REPAIRED IF COVERED. THE RS-4I STIMULATOR DEVICE WAS TESTED AND CONFIRMED TO NEED REPLACEMENT BATTERIES. FURTHER TESTING IS ONGOING. FOLLOW-UP INFORMATION WILL BE SUPPLEMENTED TO THE MDR. LABELING PROVIDED WITH THE STIMULATOR INCLUDED A WARNING THAT "SEVERE SPASM OF THE LARYNGEAL AND PHARYNGEAL MUSCLES MAY OCCUR WHEN PADS ARE POSITIONED OVER THE NECK OR MOUTH. THE CONTRACTIONS MAY BE STRONG ENOUGH TO CLOSE THE AIRWAY OR CAUSE DIFFICULTY IN BREATHING." MDR FILED - (B)(4) 2010.

Description of Event or Problem

PATIENT STATED SHE EXPERIENCED THE INABILITY TO SWALLOW DURING USE OF THE STIMULATOR WITH CONVENTIONAL ELECTRODES PLACED ON THE SIDES AND BACK OF HER NECK SEVERAL YEARS PRIOR. PATIENT DID NOT SEEK MEDICAL TREATMENT, JUST REALIZED WHEN SHE LAID DOWN SHE COULD NOT SWALLOW. PATIENT WAS ABLE TO SWALLOW AFTER A WHILE POST USE OF THE STIMULATOR. PATIENT HAD SURGERY SOMETIME AFTERWARDS AND HER PHYSICIAN TOLD HER SHE HAD AIRWAY BLOCKAGE. PATIENT CLAIMS TO STILL HAVE TROUBLE WITH SHORTNESS OF BREATH ALTHOUGH THE STIMULATOR HAS NOT BEEN USED FOR SEVERAL YEARS.