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	07/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication of any system or component failure and replacement of components was performed as a precaution only as the system has potential to be damaged from procedural handling.There are no reports of any external trauma or other events that are likely to have contributed to movement of the implanted lead.Migration of components is a known inherent risk of implantable neuromodulation systems.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2023.At the time of system activation the patient reported good pain relief.Several weeks after activating the system, the patient reported complete loss of stimulation from the left side lead.Troubleshooting and imaging was performed and found that the left side lead had migrated away from the target location.Patient reported receiving good relief on the right side and requested to postpone any intervention in order to assess pain relief using only the right side lead.On 07/19/2024 the firm received communication from the implanting physician office notifying of a planned revision procedure for this patient.On (b)(6) 2024 surgical intervention took place to place a new lead at the nerve target on the left side.During the procedure the physician elected to completely remove the existing system and place a new one out of caution.

• 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: 20084796
• Report Number: 3015425075-2024-00316
• Device Sequence Number: 7598972
• Product Code: GZF
• UDI-Device Identifier: 00812537035628
• UDI-Public: 0100812537035628112105271724052710NW909
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/22/2024

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 Expiration Date: 05/27/2024
• Device Model Number: 72011
• Device Catalogue Number: 72011
• Device Lot Number: NW909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2021
• 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