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

Model Number	71004
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/03/2024
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 treat lower back pain.The implantable pulse generator (ipg) was placed in the lower back area with leads targeting the cluneal nerve.In may 2024 the firm was notified that the patient was experiencing what was described as sudden drainage from the ipg incision site on the low back.Per the physician, there was a possibility of infection and physician was concerned that the implant had been somehow compromised.On (b)(6) 2024 a surgical procedure was performed to remove the existing nalu system, irrigate and clean the incision area, and place a new nalu system (see mdr 3015425075-2024-00220).After the system was replaced, the patient reported inadequate pain relief despite multiple reprogramming and troubleshooting attempts.Physician informed the firm that ct scans showed what appear to be mechanical issues with the patient's physiology, which would require removal of the nalu system to address.On (b)(6) 2024 the nalu system was fully explanted to allow the patient to address other physical issues.
Additional Manufacturer Narrative
There is no indication of any system or component failure.The patient appears to be experiencing physical issues unrelated to the nalu system and required explant in order to address those issues.

• 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: 20398219
• Report Number: 3015425075-2024-00376
• Device Sequence Number: 11600768
• Product Code: GZF
• UDI-Device Identifier: 00812537036120
• UDI-Public: 01008125370361201123102417261024
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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: 09/03/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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