MAUDE Adverse Event Report: Nalu Medical, Inc Nalu Neurostimulation System; Peripheral Nerve Stimulator

Model Number	71019
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The nalu sales representative (rep) reported that a defective implantable pulse generator (ipg) was discovered during perm implant.After the leads were placed and tested, impedance and paresthesia mapping were good.Moved on to tunnel the leads.After leads were tunneled, moved on to hooking up the ipg and leads.Impedance check did not clear on contact b4.Physician wanted to give ipg a depth test with therapy disc to see if there were any other issues with the ipg.During the pocketing procedure physician noticed what looked like a piece of wire protruding from the tail of the ipg.Upon closer inspection, there was in fact wire hanging out of the tail.The physician and nalu rep both agreed that this ipg should not be utilized due to the bad impedance reading on contact b4 and the wire protruding from the tail of the ipg.A new ipg was used to complete the case.There was no reported patient harm or injury.
Additional Manufacturer Narrative
After conducting a post-acquisition, retrospective review of nalu peripheral nerve stimulation complaint records, boston scientific determined that this event meets mdr reporting criteria.The following mdr information is being submitted as part of capa investigation pcar42.The reported device was returned for evaluation.Visual inspection found that there is an exposed wire poking out of a slice in the connector boot.On the opposing side, there is a similar slice facing the same direction, as well as a slice near the pushing tool port.The damage to the connector boot appears to have been done with an object akin to forceps or scissors.The device was likely damaged during surgery due to components that are sensitive to handling with surgical tools.

• 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 -724
• Manufacturer (Section G): Nalu Medical, Inc; 2320 faraday ave; suite 100; carlsbad CA 92008 -724
• Manufacturer Contact: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008--724
• MDR Report Key: 50840744
• Report Number: 3015425075-2026-00686
• Device Sequence Number: 18657071
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/02/2025
• Device Model Number: 71019
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown