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	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication of any system or component failure and the communication issues reported appear to be directly related to the location of the implant in relation to the patient's body habitus.It is unclear if the ipg was placed in a less optimal position initially or if the patient's experienced weight or other physiological changes after implant that may have impacted the tissue quality around the device and contributed to the communication issues.The system was replaced out of caution to avoid any potential damage that may have from handling during the repositioning.The explanted components were not returned to the firm and are unavailable for further testing or evaluation by the firm.
Event or Problem Description
Patient was implanted with the nalu peripheral nerve stimulator (pns) system on (b)(6) 2022 and subsequently complained of an uncomfortable pressure at the incision site.Physician determined that the implantable pulse generator (ipg) was positioned over a spinous process and that was leading to the patient's discomfort.Surgical procedure was performed on (b)(6) 2022 to move the ipg to a more comfortable position for the patient.See mdr 3015425075-2023-00145.After the revision procedure, the patient reported that they sustained a fall and subsequently experienced reduced efficacy of the nalu system.Investigation found migration of an implanted lead.Rather than perform a second revision on the existing system, the patient and physician elected to remove the system to allow for full healing.A full system explant was performed in (b)(6) 2022 (see mdr 3015425075-2023-00173) and the patient was re-implanted with a nalu pns system on (b)(6) 2023.The new system was placed such that the ipg is in the lower back area and the leads targeted the cluneal nerve.On (b)(6) 2025, more than one year after the implant, the patient contacted nalu product support to request assistance with communication issues between the ipg and the external therapy discs.Evaluation found that the ipg was implanted in a location of the lower back that fell underneath a roll of tissue, causing excess tissue to fall between the ipg and the external components, which led to intermittent communication and thus lack of pain relief from the system.On (b)(6) 2025 the existing system was removed and a new nalu pns system was placed in a different location on the patient's back so as to avoid excess tissue and skin rolls.

• 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: 21915929
• Report Number: 3015425075-2025-00169
• Device Sequence Number: 15635666
• Product Code: GZF
• UDI-Device Identifier: 00812537036120
• UDI-Public: (01)00812537036120(11)210511(17)240511
• 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: 2023
• 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): 04/27/2025

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: 05/11/2024
• 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: 04/22/2025
• Initial Report FDA Received Date: 04/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2021
• 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