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

Model Number	72002
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2023 after participating in a trial phase and wear experience with nalu.The implantable pulse generator (ipg) was placed in the lower back area and the implanted leads were placed in the area of c2 to target the occipital nerve.In (b)(6) 2024 the patient reported pain levels had decreased from 8/10 down to 1/10 and returned to work.In (b)(6) 2024 the patient reported loss of therapy from the system.Imaging was performed and field investigation concluded that the implanted leads had migrated away from the intended nerve target.A surgical revision was performed on (b)(6) 2024 with the intention of repositioning the migrated leads.During the procedure the ipg was damaged and required replacement.
Additional Manufacturer Narrative
Patient is reported to work in a physically demanding job and also is caregiver for young children at home.Migration is a known inherent risk of implantable neuromodulation systems, however it is potentially significant that the lead migration took place shortly after the patient returned to work.

• 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: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 20077033
• Report Number: 3015425075-2024-00313
• Device Sequence Number: 6574107
• Product Code: GZB
• UDI-Device Identifier: 00812537033624
• UDI-Public: 0100812537033624112204181725041810R2533
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/16/2024

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: 04/18/2025
• Device Model Number: 72002
• Device Catalogue Number: 72002
• Device Lot Number: R2533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2022
• 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