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

Model Number	72011
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A nalu representative participated in pre-implant surgical planning with the implanting physician and reports that, while performing the initial implant on (b)(6) 2024, the physician elected to deviate from the initial plan of approach and place the system utilizing a single incision instead of using a second incision to place the left side lead.Changing the approach caused the planned location for the implantable pulse generator (ipg) to be inaccessible and a new location was chosen during the procedure.Eliminating the second incision site also affected the accessibility of the location for the left side lead.The lead was able to be placed from the single right side incision site, but the anchors were unable to be placed due to limited access, so the lead was sutured into place instead of using the anchors.Migration is a known inherent risk of implantable neuromodulation systems, however it is likely in this case that the implanting technique affected the stability of the lead and allowed the component to migrate.
Event or Problem Description
On (b)(6) 2024 the patient was implanted with a nalu pns system after a successful trial and wear study.The nalu system was successfully activated and the patient reported good pain relief.On (b)(6) 2024 the patient reporting feeling a sensation on (b)(6) 2024 as if one of the leads had moved down and away from the initial implant location.Xray imaging confirmed the patient claims of migration of the left side lead.On (b)(6) 2025 a surgical revision was performed to reposition and re-suture the migrated lead.The physician was able to access the lead using a single incision and reposition and suture the lead at the desired location.No implanted components were removed or replaced and no new components were introduced 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: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 21371128
• Report Number: 3015425075-2025-00051
• Device Sequence Number: 8459455
• Product Code: GZF
• UDI-Device Identifier: 00812537035628
• UDI-Public: (01)00812537035628(11)240215(17)270215(10)9456605
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/07/2025

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: 72011
• Device Catalogue Number: 72011
• Device Lot Number: 9456605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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