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	Impaired Healing (2378)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no reports of confirmed or suspected infection and no indication that the nalu device contributed to the incision site failing to heal.Poor healing is a known inherent risk of surgical procedures.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2023 to treat right shoulder pain.On (b)(6) 2024 the firm was notified that the surgical incision had failed to heal and the implantable pulse generator (ipg) was exposed through the incision site.A full system explant was performed on (b)(6) 2024 due to the incision site failure to heal.The firm was not notified of the procedure ahead of time and thus unable to be present.

• 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: 19001446
• Report Number: 3015425075-2024-00107
• Device Sequence Number: 18251231
• Product Code: GZF
• UDI-Device Identifier: 00812537030999
• UDI-Public: 01008125370309991120090817230908
• 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
• 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): 03/28/2024

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: 09/08/2023
• 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: 03/01/2024
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2023
• 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