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

Model Number	71009
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of records found no previous complaints or incidents during the two years the nalu system was implanted and in use, it is notable that there are records of three inquiries around mri conditionality in (b)(6) of 2023.Mri was being requested for shoulder area, which was not an area being treated by the nalu system.After reviewing the patient's records with nalu, there does not appear to be any indication that the system was malfunctioning.Suspect the request for explant was related to the shoulder mri inquiries.
Event or Problem Description
Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2021 to treat lower back pain.In (b)(6) 2023 the patient indicated a desire to remove the system due to inadequate pain relief.Patient was offered reprogramming and troubleshooting to improve satisfaction with the system, patient refused.A full system explant was performed on (b)(6) 2023 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: 18592777
• Report Number: 3015425075-2024-00039
• Device Sequence Number: 8183106
• Product Code: GZF
• UDI-Device Identifier: 00812537035604
• UDI-Public: 01008125370356041120091417230914
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted 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): 01/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2023
• Device Model Number: 71009
• Device Catalogue Number: 71009
• 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: 12/28/2023
• Initial Report FDA Received Date: 01/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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: Hospitalization; Other
• Patient Sex: Unknown