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

Model Number	72003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator trial system on (b)(6) 2024.Throughout the trial the patient noted occasional spotting of blood/discharge on the surgical dressing at the lead insertion site.Patient declined dressing changes while the trial system was in place.On (b)(6) 2024 the trial system was removed as planned.On 06/28/2024 the firm was notified that the patient had been hospitalized on (b)(6) 2024 for a blood infection.Throughout the trial process, the patient reported no swelling, drainage, odor, temperature change, or other signs of infection at the insertion site.One week after the trial ended and leads were removed as planned, the patient was admitted to the hospital.After being admitted to the hospital, the patient shared with a firm representative that they were taking oral antibiotics during the nalu trial for a dental abscess.The presence of the abscess and antibiotics were not shared with the firm until a full week after the trial ended.
Additional Manufacturer Narrative
Patient perception is that the nalu system is the source of the blood infection however the source of infection in the blood is not conclusively known since the dental abscess and the nalu trial dates overlapped.B infection origination at the lead insertion site is unlikely, however cannot be fully ruled out with the information available.

• 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: 19826605
• Report Number: 3015425075-2024-00285
• Device Sequence Number: 20999208
• Product Code: GZF
• UDI-Device Identifier: 00812537033631
• UDI-Public: 01008125370336311123110917261109109455787
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/25/2024

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: 11/09/2023
• Device Model Number: 72003
• Device Catalogue Number: 72003
• Device Lot Number: 9455787
• 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: 06/28/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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