MAUDE Adverse Event Report: NALU MEDICAL, INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number	71020
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was initially suspected that swelling at the implant site was contributing to the connectivity issues.It was also thought that possibly the patient required some additional training and time to learn how to use the external devices.Ultimately the ipg was confirmed to have been the source of the connectivity issues.The information provided by the patient is unclear in determining if the connectivity issues had resolved and then reappeared later, or if the connectivity issues had been ongoing the entire time the system has been implanted.The information available is insufficient to determine if the ipg was placed beyond the recommended depth initially or if it migrated after the implant.It was also noted that there may have been persistent procedural swelling at the implant site, which may have affected the ipg stability as well.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 targeting the coccygeal nerve.Approximately 7 weeks after the implant procedure, on 08/29/2024, the patient reported that one of the external therapy discs would not connect to the implantable pulse generator (ipg).Field troubleshooting found that the disc was functioning well and suspicion at that point was ipg positioning.After allowing additional time for the implant site swelling to reduce and educating the patient on therapy disc placement, the connectivity issues appeared to have been resolved.In (b)(6) 2025 the patient asserted that no further intervention would be required.The patient used the syserm for more than a year before again reporting in (b)(6) 2026 to the medical provider that the connectivity challenges were persisting and the patient wanted to pursue ipg revision.On (b)(6) 2026 the existing ipg was removed from the original pocket location at the lower back area and relocated to the abdominal area to allow easier access for external device placement.A lead extension was added to accomodate the new position of the ipg.Imaging performed after relocation confirmed the ipg was in an appropriate position and testing confirmed the system was functioning as expected.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008
• 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: 25356549
• Report Number: 3015425075-2026-00055
• Device Sequence Number: 10653367
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: (01)00812537036182(11)240123(17)270123
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 06/01/2026

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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