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

Model Number	71004
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with the nalu peripheral nerve stimulator on (b)(6)2022 to treat lower back pain.After having been implanted, the patient reported that the reduction in pain levels lead to a more active lifestyle and significant weight loss.After having lost approximately 75 pounds, there became an issue with connectivity between the nalu implantable pulse generator (ipg) and the external therapy discs.A pocket revision was performed on (b)(6)2023 to place the ipg in a more optimal location for connectivity.No components were removed or replaced during the procedure.See mdr 3015425075-2023-00098.After repositioning the ipg, the patient continued to lose weight and eventually reported a loss of therapy from the system.Troubleshooting in the field found that the ipg was no longer parallel to the skin surface, both implanted leads had also migrated, and there was an open circuit error reported on one contact of one of the leads.On (b)(6) 2025 a surgical revision was performed to remove the existing nalu system and place a new system.
Additional Manufacturer Narrative
The original location of the ipg displayed a loss of tissue due to the patient's weight loss, resulting in the ipg pocket becoming unstable and allowing the device to migrate within the pocket.After repositioning the ipg, the patient continued to lose weight, contributing to ongoing issues with tissue stability where the nalu system was implanted.It is likely that the tissue changes related to weight loss allowed the ipg and leads to migrate.The migration of components likely caused a slight fracture of internal components, causing the open circuit error.Although migration is a known inherent risk of implantable neuromodulation systems, this case appears to be directly related to the patient's changing weight and subsequent tissue instability.

• 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: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 21728631
• Report Number: 3015425075-2025-00106
• Device Sequence Number: 3809138
• Product Code: GZF
• UDI-Device Identifier: 00812537033594
• UDI-Public: (01)00812537033594(11)220125(17)250125
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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): 03/30/2025

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: 01/25/2025
• 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: 02/28/2025
• Initial Report FDA Received Date: 03/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2022
• 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