NALU NEUROSTIMULATION SYSTEM
Received Dec 13, 2021 · Event occurred Nov 29, 2021
Report 3015425075-2021-00023 · MDR key 12986179
Device
Generic name
Peripheral Nerve Stimulator
Manufacturer
Nalu Medical IncModel number
71004Catalog number
71004
Lot number
A00567
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT HAD TWO 25CM FOUR TINED LEADS EXPLANTED. DURING REMOVAL, THE LEADS TORE JUST ABOVE THE PROXIMAL ELECTRODE ON BOTH LEADS, LEAVING BEHIND ALL FOUR ELECTRODES ON EACH LEAD. PATIENT WAS CLOSED WITH THE ELECTRODES INSIDE. THE ELECTRODES WILL BE REMOVED DURING AN UPCOMING SURGERY.
Description of Event or Problem
PATIENT HAD TWO 25CM FOUR TINED LEADS EXPLANTED. DURING REMOVAL, THE LEADS TORE JUST ABOVE THE PROXIMAL ELECTRODE ON BOTH LEADS, LEAVING BEHIND ALL FOUR ELECTRODES ON EACH LEAD. PATIENT WAS CLOSED WITH THE ELECTRODES INSIDE. THE ELECTRODES WILL BE REMOVED DURING AN UPCOMING SURGERY.