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

Model Number 71005

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

The patient reported good pain relief with the system upon implant when the system was connected.There is no indication that the system or any of its components failed or malfunctioned.The initial plan was to move the existing system to a new pocket location, however the ipg was damaged during the procedure so a new component was placed into the new pocket.The damaged ipg was discarded by the medical facility and unavailable for any further testing by the firm.Based on patient reports of receiving therapy, it appears that there is no system issue and that the communication issues are directly related to the placement of the implant.

Event Description

Patient was implanted with the nalu spinal cord stimulator on (b)(6) 2022 targeting the thoracic nerve.Immediately upon activation of the implant, the patient was found to have difficulty with communication between the implantable pulse generator (ipg) and the external therapy discs.While the patient reported good pain relief from the system, it was determined that the placement of the ipg was not optimal for communication due to the patient's physiology.On (b)(6) 2023 a surgical revision was performed to place a new ipg into a new pocket location.

• 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: 18508631
• MDR Text Key: 332868686
• Report Number: 3015425075-2024-00016
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371121112917241129
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other