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

Model Number	71004
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication of any system or component failure.Explant took place due to mri conditionality only.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2022.In 2024 the patient informed a nalu representative that an mri was required and thus an explant of the nalu system was being requested.On (b)(6) 2024 a full system explant was performed to allow the patient to move forward with the mri testing.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 20276173
• Report Number: 3015425075-2024-00346
• Device Sequence Number: 15247538
• Product Code: GZF
• UDI-Device Identifier: 00812537033594
• UDI-Public: 01008125370335941121051117240511
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Type of Report: Initial
• Report Date (Section B): 09/06/2024

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
• Device Expiration Date: 05/11/2024
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 09/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2021
• 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