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

Model Number	71005
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the revision, the physician confirmed that the original placement of the ipg appeared to be slightly beyond the optimal depth for good communication.The issues were reported immediately after activating the system, indicating that the initial placement was likely the issue.
Event or Problem Description
Patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2022 to treat lower back pain.After activating the system the patient reported persistent issues with communication between the implantable pulse generator (ipg) and the external therapy discs.A surgical revision was performed on (b)(6) 2024 to move the ipg from the flank area to approximately 1.5 inches inferior to a flatter area on the back as well as bringing the ipg more superficial to improve communication.During the procedure the ipg was found to be surrounded by scar tissue and was damaged while attempting to remove the device.A new ipg was introduced in the new location.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008 2377
• 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: 19822229
• Report Number: 3015425075-2024-00278
• Device Sequence Number: 18295910
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371122042617250426
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/24/2024

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: 04/26/2025
• Device Model Number: 71005
• Device Catalogue Number: 71005
• 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: 06/26/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2022
• 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