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

Model Number	72003
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication of any component failure and no indication of any issues with the initial trial system implant or removal.The patient was instructed to not remove the bandages at home, however the patient failed to follow instructions, resulting in a portion of the implanted lead requiring surgical removal.Removal of trial leads is standard practice and part of the trial process.In this case an additional and more invasive procedure was required due to patient having tampered with the components and cut one of the leads.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator trial system on (b)(6) 2024 to treat shoulder pain.During use of the trial system the patient communicated the desire to remove the bandages from the insertion site and was instructed to leave the bandages intact and not remove.When the patient arrived to the clinic to remove the trial system, the bandages were removed and the trial leads were not present or not visible at the insertion site.Patient reported that the leads may have "come loose" and admitted to removing the bandages at home.Confirmed that one of the trial leads was in the bandage, however the second lead was unable to be visually located.Patient and wife stated that during bandage removal at home they had cut something but were unsure what had been cut.Xray imaging confirmed that a piece of one of the trial leads had been cut off and remained in the patient's shoulder.An additional, unanticipated procedure was performed on 29feb2024 to remove the remaining trial lead from the patient's shoulder.

• 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: 19001312
• Report Number: 3015425075-2024-00106
• Device Sequence Number: 21191665
• Product Code: GZF
• UDI-Device Identifier: 00812537033631
• UDI-Public: 0100812537033631112310271726102710CWK330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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 Model Number: 72003
• Device Catalogue Number: 72003
• Device Lot Number: WK330
• 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: 02/29/2024
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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