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

Model Number	71005
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/27/2024
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 treat back pain.During a follow-up in april 2024 the patient reported that pain levels had decreased from 7/10 down to 3/10.Patient later reported onset of new pain symptoms at the location of the implantable pulse generator (ipg) and stimulation outside of the desired location.During a physical visit the implant site was visually assessed and found that the ipg had migrated to a location that was over the spinal column.Imaging was taken and confirmed that the ipg was no longer in its original location and the implanted leads had also migrated away from the intended target, causing the unwanted stimulation.Further assessment found that the pocket created during the implant procedure was too large and did not provide the desired stability for the ipg, allowing it to migrate and cause pain.A surgical procedure was performed on (b)(6) 2024 to create a new pocket and reposition the existing ipg off the spinal column.During the procedure, the implanted leads were damaged and required replacement.The new leads were positioned back at the desired nerve target to restore therapy for the patient.
Additional Manufacturer Narrative
There are no indications of system or component malfunction.The implanting technique did not place the ipg in a stable pocket, allowing it to shift and lead to pain for the patient.It is likely that the movement of the ipg also pulled the leads out of position as well.There are no indications of system or component failure, as evidenced by the ipg remaining implanted and in use.There are no reports of external trauma or activities that are likely to have led to device movement.Migration of components is a known inherent risk of implantable neuromodulation devices.

• 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: 19826594
• Report Number: 3015425075-2024-00282
• Device Sequence Number: 8665774
• Product Code: GZB
• UDI-Device Identifier: 00812537033600
• UDI-Public: 01008125370336001123061217240611
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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: 06/11/2024
• 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: 06/25/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• 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