MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number 72006

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/10/2023

Event Type  Injury  

Manufacturer Narrative

Patient event during the surgical procedure is not likely caused by the nalu system itself.Cessation of breathing function is a known inherent risk of anesthesia associated with surgical procedures.There are no reports of external trauma or other events that are likely to have caused or contributed to lead migration and subsequent fracture.Migration of components is a known risk of implantable neuromodulation systems and likely contributed to the subsequent fracture of the lead.

Event Description

Patient was implanted with the nalu peripheral nerve stimulator on (b)(6) 2023 to treat pelvic area pain.After programing the patient reported receiving approximately 75% pain relief in the targeted areas, however the patient reported new onset of hip pain after activation of the system.Physician performed a ganglion impar neurotomy to address the hip pain on 07jun2023 and fluoroscopy performed during the procedure showed that both of the nalu implanted leads had migrated superiorly from the initial implant location, possibly hitting a branch nerve and contributing to hip pain.A surgical revision was performed on (b)(6) 2023 and found that one of the implanted leads had also fractured.Both implanted leads were replaced during the procedure and new leads were placed in a more optimal location.During the procedure, after replacing both leads and prior to closure, the patient's breathing ceased and measures were required to restore breathing.After stabilizing the patient's vital signs, the new leads were connected to the existing implantable pulse generator (ipg) and intra-op testing was completed.Patient verbalized receiving paresthesia during testing, all impedance and depth checks were performed, and the procedure was completed with no further complications.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18280199
• MDR Text Key: 329889207
• Report Number: 3015425075-2023-00301
• Device Sequence Number: 1
• Product Code: GZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72006
• Device Catalogue Number: 72006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other