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

Model Number	71007
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explant procedure was attended by a nalu representative who noted that the implantable pulse generator (ipg) was placed in a location on the calf area with a very small surface, which caused the external therapy discs to not seat flush against the skin.It is likely that the positioning of the ipg and thus the external components caused disruptions in therapy and led to lack of adequate pain relief.There was no obvious malfunction of the system or any of its components at the time of explant.The suboptimal positioning of the device based on patient anatomy likely led to the patient frustration and subsequent explant.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2023 to treat foot pain.In (b)(6) 2024 the firm was notified that the patient and spouse were requesting to have the system explanted due to inadequate pain relief.A representative of the firm reached out to the patient to offer troubleshooting.Patient and spouse reported frustration with the system and declined troubleshooting.A full system explant took place on (b)(6) 2024 per patient request.

• 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: 19988876
• Report Number: 3015425075-2024-00303
• Device Sequence Number: 20978836
• Product Code: GZF
• UDI-Device Identifier: 00812537030999
• UDI-Public: 01008125370309991121091417240914
• 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): 08/14/2024

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: 09/14/2024
• 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: 07/15/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2021
• 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