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	04/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The communication issues were reported by the patient within 2 weeks of having the system implanted.The patient was noted to have a very high bmi and possible fluid in the implant area, possibly contributing to instability of the implant.Observed patient behavior also suggests that there is a possibility that the patient had manually palpated the ipg site and disrupted the healing process, also potentially contributing to device instability and migration.Movement of the ipg may have created pressure on the leads and caused the slight lead migration identified.There are no reports from the patient of unusual activities or traumas during the healing process.
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2025 to treat lower back pain.The implantable pulse generator (ipg) was placed in the lower back area with the implanted leads targeting the cluneal nerve.Within 2 weeks of implant, the patient reported some issues with communication between the ipg and the external therapy discs.One of the therapy discs appeared to have more issues than the other and was replaced in (b)(6) 2025, however the communication issues persisted.Ultimately it was determined that the ipg had migrated within the pocket to no longer be sitting parallel to the skin surface, causing the communication issues.The patient also noted that one of the implanted leads did not appear to be providing the same coverage as was experienced during the trial.Very slight migration was noted at the right lead, so the patient was still receiving therapy from the lead but not as effective as expected.On (b)(6) 2025 a surgical revision was performed to remove the migrated ipg and place a new one into the same pocket location but seated parallel to the skin surface.Both implanted leads were replaced during the procedure as well as a precaution due to potential for handling damage during the procedure.

• 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: 22021168
• Report Number: 3015425075-2025-00148
• Device Sequence Number: 9484983
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: (01)00812537036182(11)231102(17)261102
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/07/2025

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: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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