InjuryPNS
NALU NEUROSTIMULATION SYSTEM
Received Feb 9, 2022 · Event occurred Jan 11, 2022
Report 3015425075-2022-00003 · MDR key 13499985
Device
Generic name
Peripheral Nerve Stimulator
Manufacturer
Nalu Medical IncModel number
71020Catalog number
71020
Lot number
N/A
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Female
- Post Operative Wound Infection
- Post Operative Wound Infection
Narrative
Description of Event or Problem
PATIENT WAS IMPLANTED WITH IPG DEVICE ON (B)(6) 2021. ON (B)(6) 2022, PATIENT REPORTED POTENTIAL INFECTION AT THE IMPLANT SURGICAL SITE. PHYSICIAN REFERRED PATIENT TO HER LOCAL URGENT CARE. A PATIENT FOLLOW-UP ON (B)(6) 2022 CONFIRMED AN (B)(6) INFECTION THAT IS BEING TREATED WITH ANTIBIOTICS. PATIENT CONTINUES TO RECEIVE PAIN RELIEF FROM HER DEVICE.