MAUDE Adverse Event Report: NALU MEDICAL, INC NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR

Model Number	72001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prior to migration of the leads, there were no complaints or reports of any issues with the function of the nalu system or any of its components.The impedance errors noted during the revision procedure were not identified prior to that date, thus it is likely that the leads and ipg sustained some handling damage while attempting to reposition the system.The patient was initially implanted in florida and the revision took place in new york.It is unclear when the patient relocated or if the change in therapy correlates to the relocation process.There are no other known events leading up to the change in therapy or discovery of lead migration.
Event or Problem Description
The patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2025 to treat lower back pain.The system was implanted such that the leads were targeting the lumbar nerve in approximately t8/t9 location.After using the system for some time it was discovered that the leads had migrated away from the original implant location.On (b)(6) 2026 a surgical revision was performed to reposition the leads.During the procedure the leads appeared to sustain some handling damage and ultimately were replaced with new leads that were positioned at the top of t7 location to provide improved pain relief for the patient.During the revision procedure the system returned impedance errors both before and after replacing the leads.Introducing a new implantable pulse generator (ipg) removed the impedance errors.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• 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: 24442141
• Report Number: 3015425075-2026-00013
• Device Sequence Number: 16045587
• Product Code: GZB
• UDI-Device Identifier: 00812537037202
• UDI-Public: (01)00812537037202(11)250221(17)280221(10)9458738
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2026
• 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): 02/25/2026

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: 72001
• Device Catalogue Number: 72001
• Device Lot Number: 9458738
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• 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