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

Model Number	72011
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant was performed after patient sustained a fall.Migration of the implanted lead was directly related to the patient fall and is a known risk of implantable neuromodulation systems.Patient has been re-implanted with the nalu system and review of records found no further incidents.
Event or Problem Description
Patient reports that they sustained a fall and subsequently found migration of an implanted lead.Patient had undergone a previous revision due to discomfort with the placement of the implant (see mdr 3015425075-2023-00145.Rather than perform a second revision on the exisitng system, the patient and physician elected to remove the system to allow for full healing.The system was explanted in (b)(6) 2022.Exact date of explant is unknown at this time.Patient was re-implanted with the nalu system on (b)(6) 2023.

• 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
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 17442088
• Report Number: 3015425075-2023-00173
• Device Sequence Number: 2531184
• Product Code: GZF
• UDI-Device Identifier: 00812537035628
• UDI-Public: 0100812537035628112006261723062610KL265
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 08/02/2023

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: 06/26/2023
• Device Model Number: 72011
• Device Catalogue Number: 72011
• Device Lot Number: KL265
• 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: 12/31/2022
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• 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