MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number	71003
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the initial implant procedure for this patient, intra-op testing showed appropriate depth and feedback from the implantable pulse generator (ipg).After noting communication problems, ultrasound imaging was performed showing the ipg was at a depth of 1.5cm and that the ipg was actively migrating within the pocket when the patient moved to an upright position, further contributing to the communication issues.During the revision procedure, the physician elected to leave the original ipg header in the original pocket and create a new pocket for the new ipg.Patient reports significant and sustained pain relief after the revision.
Event or Problem Description
Patient was implanted with the nalu peripheral nerve stimulator on (b)(6) 2023, targetting the cluneal nerve to treat lower back pain.The system was activated on (b)(6) 2023.After activating the system, the patient reported problems with communication between the implantable pulse generator (ipg) and the external therapy discs.Testing confirmed that the ipg had migrated after being implanted, thus making communication with the therapy discs problematic.A surgical revision was performed on (b)(6) 2023, replacing the ipg.The original ipg was left in the existing pocket with a new pocket being created for the replacement ipg.Patient reports they are receiving sustained significant pain relief and the communication issues have been resolved with the ipg in the new location.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 16950935
• Report Number: 3015425075-2023-00072
• Device Sequence Number: 19699529
• Product Code: GZF
• UDI-Device Identifier: 00812537036113
• UDI-Public: 01008125370361131122031417250314
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/17/2023

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: 03/14/2025
• Device Model Number: 71003
• Device Catalogue Number: 71003
• 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: 04/18/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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