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	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no reports of any external trauma or excessive exertion from the patient.There is no indication that the nalu system or its components failed or malfunctioned.The implanted leads were replaced during the procedure due to potential for damaging the leads while attempting to reposition.The original implantable pulse generator remains in the patient and in use.Migration of components is a known inherent risk of implantable neuromodulation systems.
Event or Problem Description
Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023 to treat lower back pain.In (b)(6) 2023 after activating the system, the patient reported pain had been reduced to 1/10.Patient later reported loss of therapy.Troubleshooting was performed and determined that the implanted leads had migrated from the intended nerve target.Surgical revision was performed on (b)(6) 2024 to replace the migrated leads.No other components were replaced during the procedure.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 18862355
• Report Number: 3015425075-2024-00082
• Device Sequence Number: 11591708
• Product Code: GZF
• UDI-Device Identifier: 00812537035628
• UDI-Public: 0100812537035628112302011726020110UK459
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Model Number: 72011
• Device Catalogue Number: 72011
• Device Lot Number: UK459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2023
• 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 Age: 58 YR
• Patient Sex: Male