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

Model Number	71007
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient is sedentary and has a high bmi.It is possible that the patient body habitus with loose tissue and/or skin in the location of the implant potentially contributed to instability of the ipg, leading to migration and loss of communication.There are no reports of any external trauma or excessive movement that may have contributed to migration after the initial implant.Migration of components is a known inherent risk of implantable neuromodulation systems, however in this case it is also likely that the patient condition (unstable tissue quality) contributed to the device migration.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024 after undergoing a successful trial phase with nalu.The implantable pulse generator (ipg) was placed in the patient's calf area with the implanted leads targeting the inferior genicular nerve to treat infrapatellar pain.During the implant procedure, impedance and depth checks returned good results and the system was activated before the patient left the facility.Approximately one week after implant and activation, the patient reported receiving intermittent therapy and needing to secure the nalu relief band very tight to maintain connection between the ipg and the external therapy discs.Patient reported receiving therapy only when in certain positions and losing therapy upon changing positions.At the 10 day post-op visit, the nalu representative following the case confirmed the patient reports of intermittent communication.Imaging was performed and found that the head of the ipg had rotated away from the skin so that the ipg was tilted, likely causing the intermittent communication between the devices.On (b)(6) 2024 the physician performed a surgical procedure to implant a new nalu system.The physician elected to leave the original system implanted and overlay a new system on top.The ipg was position more superficial and parallel to the skin and the leads were placed in approximately the same location as the previous leads.The new system was activated on 07/25/2024 and the patient reports able to maintain consistent therapy which is providing 100% pain relief (pain level reported 0/10).

• 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: 20069343
• Report Number: 3015425075-2024-00324
• Device Sequence Number: 8662560
• Product Code: GZF
• UDI-Device Identifier: 00812537036144
• UDI-Public: 01008125370361441124020717270207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/26/2024

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: 71007
• Device Catalogue Number: 71007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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