NURO

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

THE PATIENT REPORTED THAT THE NURSE WAS HAVING A LOT OF DIFFICULTY SETTING UP A DEVICE AND THE DEVICE WAS NOT WORKING AT ONE POINT, BUT THE MANUFACTURER REPRESENTATIVE (REP) CAME IN AND RESOLVED IT. IT WAS FURTHER PROVIDED THAT THE PATIENT'S PERCEPTION OF THERAPY WAS A 2 ON (B)(6) 2017, BUT THEY STATED THAT THEIR SYMPTOM RELIEF WAS NOT WORSE THAN BEFORE THEY BEGAN TREATMENT. IT WAS JUST THEIR SYMPTOMS HAD BEEN GETTING BETTER, AND THEN THEY HAD A COUPLE OF ISSUES WHERE THEY COULD NOT GET TO THE BATHROOM. THEY ALSO REPORTED THAT 20-30 MINUTES AFTER VOIDING, THEY FELT A STRONG URGE TO VOID, BUT COULDN'T. THEY WERE SURPRISED BY THIS. IT WAS NOTED THAT THE PATIENT HAD NEUROPATHY, AND ON (B)(6) 2017 AFTER TREATMENT, THEY HAD TINGLING GOING UP BOTH OF THEIR LEGS FOR THE REST OF THE DAY. THE PATIENT HAD COMPLETED 4 SESSIONS. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.