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

Model Number	72012
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the revision the physician suggested that the location and anchoring technique contributed to the lead migration.During the initial implant the lead was placed in the back of the neck and sutured in place but no anchor was used.Per the physician, it is possible that the frequent movement of that area of the neck, combined with the lack of anchor, likely allowed the lad to move.During the revision procedure an anchor was used to secure the replacement lead.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6)2024 to treat head pain.In (b)(6) 2024 the patient reported changes in the effectiveness of therapy.Xray imaging suggested that both of the implanted leads had migrated away from the initial placement.On (b)(6)2024 a surgical revision was performed in which it was confirmed that only one of the leads had migrated and required replacement.

• 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
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 21024100
• Report Number: 3015425075-2024-00481
• Device Sequence Number: 12809917
• Product Code: GZF
• UDI-Device Identifier: 00812537035642
• UDI-Public: (01)00812537035642(11)230210(17)260210(10)VH265
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Type of Report: Initial
• Report Date (Section B): 12/26/2024

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
• Device Expiration Date: 02/10/2026
• Device Model Number: 72012
• Device Catalogue Number: 72012
• Device Lot Number: VH265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown