inforMED
InjuryPNS

NALU NEUROSTIMULATION SYSTEM

Received Jan 5, 2022 · Event occurred Dec 17, 2021

Report 3015425075-2021-00025 · MDR key 13169968

Device

Generic name

Peripheral Nerve Stimulator

Manufacturer

Nalu Medical Inc

Model number

71020

Catalog number

71020

Lot number

N/A

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Female

  • Post Operative Wound Infection
  • Post Operative Wound Infection

Narrative

Description of Event or Problem

PATIENT WAS IMPLANTED WITH AN IPG DEVICE ON (B)(6) 2021. AT HER TWO WEEK POST-OPERATION VISIT, PATIENT SHOWED SIGNS OF INFECTION AT THE IPG ENTRY SITE. PHYSICIAN PLACED PATIENT ON ANTIBIOTICS FOR TWO WEEKS.