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

Model Number	71006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
When the patient arrived at the medical facility for the explant procedure, the physician discovered that a portion of the implanted lead, as well as the lead anchor, were exposed and protruding through the skin on the patient's lower back.The patient had not previously notified medical staff or nalu personnel about the lead exposure.Primary reason for explant remains covid-related complications.There are no indications or allegations of any system or component failure.The cause of the lead exposure is unknown and it is not clear if the lead was exposed through a dehisced surgical incision or if the lead eroded through the skin at a different location.
Event or Problem Description
Patient was implanted with a nalu spinal cord stimulator system on (b)(6)2024.The implantable pulse generator (ipg) was placed in the lower back with the implanted lead contacts targeting the thoracic nerve in the vicinity of t8-t10.On (b)(6)2024 the patient presented to the medical facility for an explant.Per the facility, the procedure was considered urgent and was being performed due to covid-related complications.A full system explant was performed on (b)(6)2024.No nalu personnel were permitted to be present for the procedure due to patient's covid status.The explanted device was discarded by the facility.

• 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: 21187578
• Report Number: 3015425075-2025-00030
• Device Sequence Number: 8603199
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: (01)00812537036137(11)240111(17)270111
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2025
• 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): 01/17/2025

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: 71006
• Device Catalogue Number: 71006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/18/2025
• 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