InjuryPNS
NALU NEUROSTIMULATION SYSTEM
Received Jan 28, 2022 · Event occurred Jan 11, 2022
Report 3015425075-2022-00001 · MDR key 13389068
Device
Generic name
Peripheral Nerve Stimulator
Manufacturer
Nalu Medical IncModel number
72006Catalog number
72006
Lot number
N/A
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Post Operative Wound Infection
- Post Operative Wound Infection
Narrative
Description of Event or Problem
ON (B)(6) 2022, PHYSICIAN DISCOVERED THAT PATIENT HAD AN INFECTION AT THE INCISION SITE. THE PHYSICIAN ELECTED FOR AN EXPLANT OF THE DEVICE WHILE PATIENT HEALS. THE EXPLANT WAS PERFORMED (B)(6) 2022.
Description of Event or Problem
ON (B)(6) 2022, PHYSICIAN DISCOVERED THAT PATIENT HAD AN INFECTION AT THE INCISION SITE. THE PHYSICIAN ELECTED FOR AN EXPLANT OF THE DEVICE WHILE PATIENT HEALS. THE EXPLANT WAS PERFORMED (B)(6) 2022.