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

Model Number	71005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient was not seen by any nalu representatives for troubleshooting after the system was activated.The patient's daughter reported verbally that after the implant the patient had developed new onset groin pain as well as having pain at the site of the ipg.The daughter reported that the ipg was able to be palpated and that manually moving the ipg would provide temporary pain relief, however the ipg would eventually move back into the painful location in the pocket and the pain would return.Patient's daughter additionally reported that the nalu system was not providing pain relief at the intended area of treatment.It is unclear when the patient or family began manually manipulating the implanted ipg and how this may have affected the patient's pain symptoms.The patient was not seen for any reprogramming or troubleshooting prior to seeking a new provider, thus the cause of the pain symptoms and lack of therapy was unable to be diagnosed or corrected.
Event or Problem Description
After participating in a successful trial phase with nalu, the patient was implanted with a nalu spinal cord stimulation system on (b)(6) 2025, targeting the lumbar nerve to treat lower back and lower extremity pain the system was activated on (b)(6) 2025 on (b)(6) 2025 a nalu representative was contacted by the patient's daughter who stated that the patient was complaining of groin pain that had begun after the nalu system was implanted.The patient's daughter requested records of the implant procedure as the family was opting to seek a second opinion regarding the new pain symptoms.On (b)(6) 2025 the patient's daughter reported to a nalu representative that the system had been explanted that day due to pain at the site of the implantable pulse generator (ipg).

• 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: chelsea gutierrez ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7144010608
• MDR Report Key: 22552665
• Report Number: 3015425075-2025-00212
• Device Sequence Number: 9894437
• Product Code: GZB
• UDI-Device Identifier: 00812537037189
• UDI-Public: (01)00812537037189(11)241028(17)271028
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 07/16/2025

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 Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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