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

Model Number	71004
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2022 to treat lower back pain.After having the implant performed the patient gained a significant amount of weight, causing disruption in communication between the implantable pulse generator (ipg) and the external therapy discs.A surgical revision was performed on (b)(6) 2024 to move the ipg from the lateral lower back to a more medial location on the lower back to correct the communication issue.No components were explanted or replaced during the procedure.
Additional Manufacturer Narrative
There is no allegation or indication of any system or component failure as evidenced by all components remaining implanted and in use.The communication issues noted by the patient were found to be directly related to the patient condition, specifically weight change.

• 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: 19543992
• Report Number: 3015425075-2024-00222
• Device Sequence Number: 12649850
• Product Code: GZF
• UDI-Device Identifier: 00812537033594
• UDI-Public: 01008125370335941122012517250125
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/14/2024

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: 01/25/2025
• 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: 05/15/2024
• Initial Report FDA Received Date: 06/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2022
• 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