MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR

Model Number	71005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no allegations of the nalu system or any components failing or malfunctioning.Patient's developed pain in additional location that was not previously identified and was not being treated with the nalu system.One lead from the existing system which was treating a known pain area was removed in order to place a lead to target the new pain area, thus treating both locations with the same system.
Event or Problem Description
Patient was implanted with the nalu spinal cord stimulator system on (b)(6) 2021 to treat lower back pain.After implant the patient reported development of pain in a new location.On (b)(6) 2022 a trial course was initiated for the additional pain location.Surgical revision was performed on (b)(6) 2022 to remove one of the implanted leads and place a new lead to better target the additional pain location.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008 2377
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 17446375
• Report Number: 3015425075-2023-00153
• Device Sequence Number: 11447033
• Product Code: GZB
• UDI-Device Identifier: 00812537033600
• UDI-Public: 01008125370336001120091417210914
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/02/2023

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: 09/14/2021
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Device Lot Number: A01118
• 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: 04/20/2022
• Initial Report FDA Received Date: 08/02/2023
• 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: Other
• Patient Sex: Unknown