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

Model Number	71005
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication of any device failure as evidenced by all original components remaining implanted and in use.The patient has a fairly sedentary lifestyle and reported no falls or other issues while recovering from the implant procedure.Migration is a known inherent risk of implantable neuromodulation systems.
Event or Problem Description
Patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2024 to treat lower back pain.Immediately upon activating the system it was noted that the communication between the implantable pulse generator (ipg) and external therapy discs was not ideal and would cause intermittent disruptions to therapy for the patient.The communication issues failed to improve after additional healing time and xray imaging confirmed the ipg had migrated beyond the recommended depth and had also rotated to no longer be parallel to the skin surface.On (b)(6) 2024 a surgical procedure was performed to reposition the existing equipment to bring the ipg to the recommended depth and position for optimal communication.The system was successfully reactivated and patient has reported getting good pain relief from the system.

• 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: 20356236
• Report Number: 3015425075-2024-00374
• Device Sequence Number: 15253842
• Product Code: GZB
• UDI-Device Identifier: 00812537037189
• UDI-Public: 01008125370371891124060717270607
• 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
• 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 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: 08/21/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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