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

Model Number	71004
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient underwent a trial and wear experience in which the they were able to experience the positioning of the system before being implanted.Patient agreed to the location of the system prior to implant and based on that trial and wear experience.Revision was performed per the patient request only and not due to any medical necessity or failure of the system.After the revision, a nalu representative worked with the patient multiple times to reprogram the device to improve pain relief.Field assessment found that all nalu components were connecting and communicating well and the system was performing as expected.Ultimately, the patient was not satisfied with the perception of the level of pain relief and requested to remove the system.There is no indication of any system or component failure.It is possible that repositioning the system caused the stimulation to be delivered to a slightly different area and reduce the level of pain relief.
Event or Problem Description
Patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2022 to treat lower back pain.On (b)(6) 2024 a surgical revision was performed to move the implantable pulse generator (ipg) to a more lateral position on the lower back, making the location more accessible for the patient to place the therapy discs.The existing implanted leads remained in use with the addition of lead extensions in order to connect to the ipg at it's new location.The existing ipg remained in use after being repositioned.On (b)(6) 2024 a nalu representative was informed by the physician that the patient had statd the nalu system was not effective and requested to remove it.Per the physician, the nalu system was explanted on (b)(6) 2024.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 21187580
• Report Number: 3015425075-2025-00033
• Device Sequence Number: 20968937
• Product Code: GZB
• UDI-Device Identifier: 00812537036120
• UDI-Public: (01)00812537036120(11)220224(17)250224
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/24/2025
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown