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

Model Number	71004
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no allegations of any system or device failure or malfunction.Communication issues were reported immediately upon implanting the system, indicating that the ipg was implanted beyond the recommended depth.All implanted components remain in use and the patient reports being happy with the therapy after moving the ipg to a more superficial location.
Event or Problem Description
Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023 and immediately reported issues with communication between the implantable pulse generator (ipg) and the external therapy discs, leading to inadequate pain relief due to intermittent therapy, troubleshooting was attempted and unsuccessful.A surgical revision was performed to move the existing ipg to a more superficial location on (b)(6) 2023.The system was activated on (b)(6) 2023 with good connectivity and providing consistent therapy.

• 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: 17956403
• Report Number: 3015425075-2023-00249
• Device Sequence Number: 5295446
• Product Code: GZF
• UDI-Device Identifier: 00812537033594
• UDI-Public: 01008125370335941120061617230616
• 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): 10/17/2023

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: 06/16/2023
• Device Model Number: 71004
• Device Catalogue Number: 71004
• 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: 09/19/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• 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