NURO
Received Nov 20, 2017
Report 3007566237-2017-04895 · MDR key 7047370
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
- Unspecified Infection
- Pain
- Therapeutic Response, Decreased
- Dysuria
- Unspecified Infection
- Pain
- Therapeutic Response, Decreased
- Dysuria
Narrative
Description of Event or Problem
THE PATIENT REPORTED THAT THEIR PERCEPTION OF THERAPY FOR AFTER THEIR 9TH SESSION WAS THAT THEY WERE WORSE THAN BEFORE AND STILL WERE. THEY WERE HURTING IN THEIR BLADDER REGION. IT WAS ALSO PROVIDED THAT THEY GOT AN INFECTION, AND WERE CURRENTLY ON ANTIBIOTICS. THE PATIENT HAD COMPLETED 12 SESSIONS. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT SINCE COMPLETED THE 12 TREATMENTS, THEIR SYMPTOMS HAD GONE BACKWARDS. THEY STATED THAT THEY WERE EXPERIENCING THEIR OLD PROBLEM OF PAINFUL URINATING. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.