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

Model Number	72007
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no reports of any excessive movement or external trauma that is likely to have caused or contributed to migration of the lead.Patient is able to continue to utilize the system as-is however will continue to experience lower levels of pain relief due to the migration of the superior lead.Migration is a known inherent risk of implantable neuromodulation devices.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat abdominal pain.Prior to implanting the permanent system, the patient had completed a trial phase with nalu and had reported pain reduction from (b)(6) down to (b)(6).During the implant procedure to place the permanent system, both ultrasound and fluorscopy imaging were used to implant the implantable pulse generator (ipg) in the lower back and place the leads targeting the intercostal nerve, mimicking the trial system placement.Patient returned to the clinic for system activation on (b)(6) 2024 and was not able to achieve the same levels of pain relief as experienced during the trial.Between (b)(6) 2024 and (b)(6) 2024 the patient had multiple appointments to reprogram the system to improve therapy.Fluoroscopic imaging confirmed that the superior lead had migrated away from the intended nerve target.On (b)(6) 2024 a surgical revision took place to attempt to replace the migrated lead.During the revision procedure, the physician utilized ultrasound imaging to visualize the location of the migrated lead in order to retrieve it and place the new lead.A total of 3 incisions were made in attempt to remove the existing lead and place a new lead, however the physician was unable to adequately view the leads with the imaging techniques utilized and ultimately closed the procedure with the original lead remaining in the migrated position and no new lead introduced.

• 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: 20647682
• Report Number: 3015425075-2024-00418
• Device Sequence Number: 20698334
• Product Code: GZF
• UDI-Device Identifier: 00812537037387
• UDI-Public: 01008125370373871124032617270326109456935
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: 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): 11/09/2024

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: 9456935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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
• Patient Sex: Unknown