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

Model Number	71019
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The nalu system was implanted and in use for aproximately 3 years before the patient requested explant.Review of records found no prior complaints or incidents on file related to this patient.Patient was unable to verbalize any specific complaint and just expressed generalized frustration.All offers of reprogramming or other troubleshooting were declined by the patient.There is no indication of the nalu system failing or malfunctioning, however the system was not released from the medical facility and the patient was not cooperative with pre-explant investigation.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2021, targeting the axillary and suprascapular nerves.In (b)(6) 2024 the patient requested to have the system explanted.A local nalu representative found that the patient was unable to verbalize any specific issue and expressed generalized frustration.Patient reported not receiving adequate pain relief and declined any troubleshooting or reprogramming offers.A full system explant was performed on (b)(6) 2024 per the 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: 19613908
• Report Number: 3015425075-2024-00237
• Device Sequence Number: 20338034
• Product Code: GZF
• UDI-Device Identifier: 00812537035604
• UDI-Public: 01008125370356041120091417210914
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/26/2024

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: 09/14/2021
• Device Model Number: 71019
• Device Catalogue Number: 71019
• 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: 05/29/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2020
• 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