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

Model Number	72007
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During troubleshooting, the nalu records were reviewed and found that there were some impedance issues noted during intra-operative testing at the original implant procedure.It is likely that the lead was not fully seated within the ipg connector or that there was fluid trapped within the connector during the implant.Either scenario would potentially allow deterioration of the circuit and eventual disconnection resulting in the open circuit readings and loss of therapy.The ipg itself does not appear to be the source of the issue as there was only one lead affected.The explanted lead was not retained for return to nalu and thus it is unable to be confirmed if there is potentially a micro fracture within the lead.It is unclear why troubleshooting was not performed immediately upon recording impedance issues during the implant procedure.
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 leads targeting the l3 vertebral body area of the medial branch nerve.In (b)(6) 2025 the patient notified a nalu representative that there was a loss of therapy on the left side of the back.Remote check of the system found open circuit impedance readings on the left side lead.The patient was advised to schedule a clinic visit and during the visit the system was confirmed to have impedance issues on one lead.Imaging was performed and showed no obvious damage or migration of the affected lead.A surgical revision was performed on (b)(6) 2025 to replace only the malfunctioning lead.The ipg and second lead remain implanted and in use while a new lead was implanted to replace the malfunctioning lead.

• 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: 22768338
• Report Number: 3015425075-2025-00253
• Device Sequence Number: 21228830
• Product Code: GZF
• UDI-Device Identifier: 00812537037387
• UDI-Public: (01)00812537037387(11)241204(17)271204(10)9458385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/10/2025

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: 72007
• Device Catalogue Number: 72007
• Device Lot Number: 9458385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2024
• 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