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

Model Number	71020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024.The implantable pulse generator (ipg) was placed in the posterior shoulder area with bilateral lead placement targeting the occipital nerve to treat head and neck pain.After implanting the system, one of the incision sites failed to heal properly and the surgical wound dehisced.On (b)(6) 2024 the patient was brought in to the operating room and placed under anesthesia for a surgical debridement.At that time the 25cm lead was buried deeper as well and the surgical wound was closed.No components were removed or replaced during the procedure and no new components were introduced.The patient was advised to not use the nalu system until the surgical site was completely healed.On (b)(6) 2025 the patient was seen in the physician's clinic for complaints of soreness at the implant site.Upon examination the patient was found to have the implanted lead exposed through the skin.A lab culture was taken to determine if infection was present, however the results are not available to the firm for confirmation.On (b)(6) 2025 the patient was brought in to the operating room and placed under anesthesia for a surgical debridement.At that time the 25cm lead was again buried deeper and was sutured to the fascia.The skin was closed with sutures over top of the incision site.No components were removed or replaced during the procedure and no new components were introduced.See mdr 3015425075-2025-00067.On (b)(6) 2025 the patient again reported soreness at the location of the ipg.Physical examination found that one of the implanted leads was again exposed through the skin.A full system explant was performed on (b)(6) 2025 due to repeated wound dehiscence and exposed implant after multiple revisions.Physician explained concerns of infection and patient agreed to the explant.The leads/ipg were exposed after dissection.All components were reported to be fully encapsulated.The ipg was removed and the leads were cut at the distal ends.Both leads were hydro-dissected and the distal end fragments were removed with no fragments remaining in the body.
Additional Manufacturer Narrative
The patient has continued to report excellent pain relief from the nalu system since the time of the initial implant activation in (b)(6) 2024 and initially refused explant due to the level of therapy being attained.There have been no indications of any system or component failure or malfunction and all original components remained implanted and in use throughout each revision procedure.No lab cultures have been made available to the firm to confirm if any type of infection is present at the wound site.The patient has not exhibited any signs or symptoms of infection.It is unclear with the information available if the implant was placed too superficial, allowing the components to press against the skin, or if possibly the patient's body was rejecting the device.

• 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: 21956700
• Report Number: 3015425075-2025-00168
• Device Sequence Number: 21131483
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: (01)00812537036182(11)240123(17)270123
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/03/2025

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
• Device Lot Number: F00418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/04/2025
• 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