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

Model Number	71005
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2024 to replace an existing neuromodulation system from a different manufacturer.In (b)(6) 2024, approximately 3 months after implanting the nalu system, the patient requested to have it removed due to difficulty placing the external components.A full system explant was performed on (b)(6) 2024.
Additional Manufacturer Narrative
The neuromodulation system used by the patient prior to implanting the nalu system did not require placement of an external component.Prior to implanting the nalu system, the patient was offered to participate in a wear study with nalu and the patient declined to participate.Wear studies are generally performed to help determine a comfortable and practical placement of the implanted and external devices.There are no allegations or indications of any nalu system or component failure or malfunction.Explant was performed per the patient request and related to usability of the external component.

• 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: 20815736
• Report Number: 3015425075-2024-00451
• Device Sequence Number: 7804411
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371124011117270111
• 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: 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): 12/01/2024

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: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 12/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown