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

Model Number 71005

Device Problem Malposition of Device (2616)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/11/2023

Event Type  Injury  

Manufacturer Narrative

During the initial implant procedure, the physician displayed difficulty tunneling to place the ipg due to patient's loose skin.The decision was made to place the ipg slightly deeper to avoid the skin issues, however this decision affected the functionality of the system.There are no indications that the nalu system or any components failed or malfunctioned.The communication issues appear to be directly related to the placement of the ipg during the implant procedure.

Event Description

Patient was implanted with the nalu spinal cord stimulator on (b)(6) 2023.Immediately after implant the patient reported poor communication between the implantable pulse generator (ipg) and the external therapy discs.Field investigation determined that the ipg was implanted beyond the recommended depth for proper communication.A surgical revision was performed on (b)(6)2023 in which a new ipg was placed in a more superficial pocket location to correct communication issues.

• 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: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18280215
• MDR Text Key: 329888885
• Report Number: 3015425075-2023-00305
• 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: 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: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other