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

Model Number	71004
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to replace a previously implanted device from a different manufacturer.The nalu implantable pulse generator (ipg) was placed at the anterior chest wall, infraclavicular location.The patient reported that swelling was present at the implant site prior to placing the nalu system, and swelling persisted for several weeks after the implant of the nalu system, delaying activation.After activating the system on (b)(6)2024 it was discovered that the ipg had migrated within the pocket, causing difficulty in communication between the ipg and the external therapy discs and subsequent inconsistent therapy for the patient.On (b)(6) 2024 a surgical procedure was performed to move the existing ipg from a vertical orientation to a horizontal orientation in attempt to provide a more stable location.No components were removed or replaced during the procedure.
Additional Manufacturer Narrative
There are no indications of any system or component failure and all original components remain implanted at the time of this report.During the revision procedure, the ipg was visually verified to have migrated so that the head of the ipg had rotated away from the skin surface and moved beyond the recommended depth for optimal communication.Both the angle and the depth of the ipg after migration contributed to the communication errors.It is unclear if the pre-existing swelling may have contributed to an unstable location for the implant and possibly contributed to migration.Migration of components is a known inherent risk of implantable neuromodulation systems.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008
• 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: 20621385
• Report Number: 3015425075-2024-00416
• Device Sequence Number: 15337020
• Product Code: GZF
• UDI-Device Identifier: 00812537036120
• UDI-Public: 01008125370361201122012817250128
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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 Expiration Date: 01/28/2025
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2022
• 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