InjuryPNS
NALU NEUROSTIMULATION SYSTEM
Received Feb 25, 2022 · Event occurred Jan 26, 2022
Report 3015425075-2022-00007 · MDR key 13603104
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
Unknown
- Post Operative Wound Infection
- Post Operative Wound Infection
Narrative
Description of Event or Problem
PATIENT WAS IMPLANTED ON (B)(6) 2020. PATIENT EXPERIENCED AN INFECTION AT IPG SITE ON (B)(6)2022, THEREFORE PNS SYSTEM WAS EXPLANTED. A CULTURE WAS TAKEN AND PATIENT WAS ORDERED WOUND CARE.
Description of Event or Problem
PATIENT WAS IMPLANTED ON (B)(6) 2020. PATIENT EXPERIENCED AN INFECTION AT IPG SITE ON (B)(6)2022, THEREFORE PNS SYSTEM WAS EXPLANTED. A CULTURE WAS TAKEN AND PATIENT WAS ORDERED WOUND CARE.