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	08/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no allegation of any system or component failure and all components remain implanted and in use.Communication issues appear to be directly related to the patient weight change, which caused the ipg to be located beyond the recommended depth for consistent communication.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 to treat shoulder pain.The system was successfully activated on (b)(6) 2024 and patient reported receiving pain relief.After activating the system the patient gained a significant amount of weight and subsequently had trouble with communication between the implantable pulse generator (ipg) and the external therapy discs.A surgical revision was performed on (b)(6)2024 to reposition the ipg to a more superficial position to accomodate the change in weight.No components were replaced during the procedure.

• 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: 20276147
• Report Number: 3015425075-2024-00344
• Device Sequence Number: 19709281
• Product Code: GZF
• UDI-Device Identifier: 00812537036120
• UDI-Public: 01008125370361201123102417261024
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/06/2024

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 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: 08/07/2024
• Initial Report FDA Received Date: 09/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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