InjuryPNS
NALU NEUROSTIMULATION SYSTEM
Received Jan 5, 2022 · Event occurred Dec 10, 2021
Report 3015425075-2021-00026 · MDR key 13169965
Device
Generic name
Peripheral Nerve Stimulator
Manufacturer
Nalu Medical IncModel number
71004Catalog number
71004
Lot number
N/A
Product problems
- Device Dislodged or Dislocated
- Device Dislodged or Dislocated
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IPG LOCATION WAS RELOCATED PER PATIENT'S REQUEST ON (B)(6) 2021. PATIENT INITIALLY ELECTED A CHEST IPG LOCATION VIA (B)(6) STUDY. PATIENT RECEIVED EXCELLENT THERAPY RESULTS, HOWEVER PATIENT EXPERIENCED SHORTER DURATION WEAR TIME WITH ADHESIVE CLIPS IN THIS LOCATION DUE TO LONG PERIODS OF SWEATING, CAUSED FROM WORKING OUTDOORS DAILY.