inforMED
InjuryPNS

NALU NEUROSTIMULATION SYSTEM

Received Nov 22, 2021 · Event occurred Oct 27, 2021

Report 3015425075-2021-00021 · MDR key 12855817

Device

Generic name

Peripheral Nerve Stimulator

Manufacturer

Nalu Medical Inc

Model number

71003

Catalog number

71003

Lot number

N/A

Product problems

  • Expulsion
  • Expulsion

Patient

Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PATIENT REPORTED THAT SHE WAS NOT RECEIVING SUFFICIENT PAIN RELIEF FROM HER NALU PNS SYSTEM. PATIENT REQUESTED AN EXPLANT. BOTH THE IPG AND LEAD WERE EXPLANTED ON (B)(6) 2021.