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

Model Number	71007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2022.In (b)(6) 2024 the patient presented to the physician's office with discomfort at the site of the implantable pulse generator (ipg), which was implanted in the medial back area, just below the ribs.The physician noted that the skin over the ipg is very thin but was not open, there was no redness, and no reports of fevers.Patient was placed on antibiotics as a precaution and instructed to stop physical therapy that had been taking place for the shoulder area.On (b)(6)2024 the firm was notified that a full system explant had taken place on (b)(6)2024 due to the discomfort of the ipg.
Additional Manufacturer Narrative
The nalu system had been in place and in use for almost two years with no indication that the ipg had migrated or otherwise malfunctioned.Patient's discomfort began after initiating physical therapy, so it is thought that the activity affected the area where the ipg was implanted, leading to irritation and discomfort.

• 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: 19102515
• Report Number: 3015425075-2024-00127
• Device Sequence Number: 20668557
• Product Code: GZF
• UDI-Device Identifier: 00812537030999
• UDI-Public: 01008125370309991119111317221113
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/12/2024

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: 11/13/2022
• Device Model Number: 71007
• Device Catalogue Number: 71007
• 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: 03/13/2024
• Initial Report FDA Received Date: 04/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2019
• 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