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

Model Number	72003
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Insufficient information is available to determine if the implanted leads were incorrectly placed during the initial procedure or if the leads migrated after being implanted.Patient successfully completed the trial with no further complications and is pending permanent implant at this time.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve trial system on (b)(6) 2023.During the trial the patient reported not getting pain relief to the targeted area.On (b)(6) 2023 a revision procedure was performed to place a new set of trial leads to better target the area of pain.It is unclear if the initial leads migrated or were incorrectly placed at the time of implant.

• 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
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 17495005
• Report Number: 3015425075-2023-00185
• Device Sequence Number: 7881245
• Product Code: GZF
• UDI-Device Identifier: 00812537033631
• UDI-Public: 0100812537033631112302091726020910UF565
• 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: 2023
• 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): 08/09/2023

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: 02/09/2026
• Device Model Number: 72003
• Device Catalogue Number: 72003
• Device Lot Number: JF565
• 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: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• 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