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

Model Number	72012
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted during the field investigation that the patient is very thin, which likely contributed to the discomfort the patient was feeling from the implanted leads.The inadequate pain relief from the system is most likely related to one of the leads having migrated.It is unknown if the patient would have still been able to achieve adequate pain relief because the patient declined all troubleshooting and reprogramming that was offered and chose instead to explant the system.The explanted components were discarded by the medical facility, however there was no indication of any system or component failure.Lack of pain relief is likely due to the migrated lead, which is a known inherent risk of implantable neuromodulation systems.
Event or Problem Description
On (b)(6) 2023 the patient was implanted with a nalu peripheral nerve stimulator system targeting the occipital nerve to treat head pain and headaches.Patient had previously completed a trial phase with the nalu system and had reported pain was reduced from 7/10 to 1/10 during the trial.After completing the permanent system implant and initial activation of the system, the patient reported inadquate pain relief and discomfort with the placement of the implanted leads.Xray imaging found one of the implanted leads had migrated.Patient was offered reprogramming to attempt to attain adequate pain relief with the lead as-is and patient refused all attempts at troubleshooting.A full system explant was performed on (b)(6) 2024 per the patient request.

• 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: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 19047825
• Report Number: 3015425075-2024-00118
• Device Sequence Number: 7223188
• Product Code: GZF
• UDI-Device Identifier: 00812537035642
• UDI-Public: 0100812537035642112102231724022310NJ811
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 04/04/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2024
• Device Model Number: 72012
• Device Catalogue Number: 72012
• Device Lot Number: NJ811
• 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: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2021
• 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