MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR

Model Number 71004

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/03/2024

Event Type  Injury  

Manufacturer Narrative

There is no indication of any malfunction or failure of the nalu system or its components.There is no evidence of component migration after the implant procedure.The patient underwent a successful trial phase prior to implanting the permanent system, however there was a six month gap between the trial and the permanent implant, allowing for changes to the patient's physique and potentially less accurate placement of the permanent system as related to the trial experience.Communication issues appear to be related to the placement of the device in relation to the patient's anatomical makeup.

Event Description

Patient was implanted with the nalu spinal cord stimulator system on (b)(6) 2023 to treat lower back pain.After the implant the patient noted some difficulty with connectivity between the implantable pulse generator (ipg) and the external therapy discs, leading to inadequate pain relief.It was determined that the issues were related to the loose skin around the ipg implant location in the lower back.A surgical revision was performed on (b)(6) 2024 to place a new ipg in a more medial position with less loose skin and tissue.Implantable leads were also replaced during the procedure as a precaution to avoid any chance of damage to the existing components while relocating them.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008 2377
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18673707
• MDR Text Key: 334950577
• Report Number: 3015425075-2024-00045
• Device Sequence Number: 1
• Product Code: GZB
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other