NURO
Received Sep 14, 2018 · Event occurred Aug 20, 2018
Report 3007566237-2018-02750 · MDR key 7877939
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 Retention
- Discomfort
- Urinary Retention
- Discomfort
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REGARDING A PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD THEIR FIRST TREATMENT ON THE DAY OF THE REPORT AND THE USED A CATHETER AND A CYSTIC CAMERA. THE PATIENT FELT SORE AFTER THE PROCEDURE, BUT STATED THAT WAS EXPECTED. NO DEVICE ISSUES OR FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.