InjuryPNS
NALU NEUROSTIMULATION SYSTEM
Received Nov 23, 2021 · Event occurred Oct 22, 2021
Report 3015425075-2021-00020 · MDR key 12862850
Device
Generic name
Peripheral Nerve Stimulator
Manufacturer
Nalu Medical IncModel number
72006Catalog number
72006
Lot number
N/A
Product problems
- Migration
- Migration
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT WAS IMPLANTED ON (B)(6) 2021. PATIENT PERFORMED EXERCISE ACTIVITY IMMEDIATELY AFTER IMPLANT PROCEDURE. FLUOROSCOPY IMAGING SHOWED THE LEAD MIGRATED FORWARD, FURTHER INTO THE POPLITEAL FOSSA. ON (B)(6) 2021 THE PATIENT HAD A REVISION SURGERY TO REMOVE THE ORIGINAL TINED LEAD AND ANOTHER LEAD WITH THE SAME SPECIFICATIONS WAS PLACED.