NURO
Received Nov 13, 2017 · Event occurred Nov 9, 2017
Report 3007566237-2017-04805 · MDR key 7026600
Device
Generic name
Stimulator,peripheral Nerve,non-implanted,for Pelvic Floor Dysfunction
Manufacturer
Medtronic NeuromodulationModel number
3533Catalog number
3533
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Urinary Tract Infection
- Urinary Tract Infection
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
THE CONSUMER REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION. IT WAS NOTED THAT THEY WERE GOING IN TOMORROW TO HAVE THE FIRST URINALYSIS TO CHECK WHETHER THEY STILL HAD ONE. THE PATIENT HAD COMPLETED 5 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. ADDITIONAL INFORMATION INDICATED THAT THE UTI WAS NOT RELATED TO THE DEVICE/THERAPY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.