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

Model Number	71005
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication of system or component failure.The patient did report feeling stimulation; however the stimulation was not in the desired location.The physician verbalized having difficulty placing the permanent leads, so it is suspected that the leads were not in the exact location as the trial, thus leading to stimulation in a slightly different location which did not provide the patient with adequate pain relief.It is unclear why the physician was having difficulty, if it was due to the device, the patient anatomy, or another factor.
Event or Problem Description
Patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2024 to treat lower back pain after successfully completing a trial phase with nalu.During the trial the patient reported good pain relief and elected to move forward with implanting the permanent system.During the implant procedure for the permanent system, the physician verbalized some difficulty with accessing the exact placement of the trial leads, but ultimately imaging appeared to show the placement of both the trial and permanent leads to be the same.After activating the system, the patient reported not feeling any stimulation at the pain location on the right side of the back, only the left side.Patient requested to revise the system.On (b)(6) 2024 a surgical revision was performed to remove the existing system and replace it with new leads in a slightly different position to better capture the patient's pain location and provide relief.

• 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: 20355405
• Report Number: 3015425075-2024-00373
• Device Sequence Number: 7171234
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371123092217260922
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/02/2024

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: 09/22/2026
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2023
• 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 Sex: Unknown