inforMED
InjuryNAM

NURO

Received Oct 19, 2017

Report 3007566237-2017-04474 · MDR key 6962611

Device

Generic name

Stimulator,peripheral Nerve,non-implanted,for Pelvic Floor Dysfunction

Model number

3533

Catalog 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
  • Urinary Tract Infection
  • Urinary Retention
  • Urinary Tract Infection

Narrative

Description of Event or Problem

THE CONSUMER REPORTED THAT THE PATIENT HAS AN URINARY TRACT INFECTION (UTI), AND WAS CURRENTLY ON ANTIBIOTICS. IT WAS ALSO INDICATED THAT THE PATIENT MAY BE RETAINING SOME URINE. THE CONSUMER INDICATED THAT THEY WOULD SCHEDULE A BLADDER SCAN. THE PATIENT HAD CURRENTLY STOPPED PERCUTANEOUS TIBIAL NEUROMODULATION (PTNM) TREATMENTS, BUT THE CONSUMER WANTED THEM TO GET BACK ON THEM AS SOON AS THE UTI CLEARED AND THE BLADDER SCAN TEST CAME BACK. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.