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

Model Number	72011
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no suspicion of any infection and the patient reports no excessive physical activity after the implant.Surgical wound dehiscence is a known inherent risk of invasive procedures.Rejection of devices is also a known inherent risk of implantable components.It is unknown if the body was rejecting the device and pushed it through a weakened area of the skin, or if the puncture site opened first and allowed the implanted component a path to migrate outward.
Event or Problem Description
Patient was implanted with a nalu peripheral nerve stimulator system on (b)(6) 2024.During a post-operation wound check on (b)(6) 2024 the patient was found to have the distal end of the implanted lead protruding through the skin at a surgical needle puncture site.The exposed lead was surgically explanted on (b)(6) 2024.The implantable pulse generator (ipg) was left implanted in anticipation of placing a new lead at a later date.

• 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: 21121597
• Report Number: 3015425075-2025-00015
• Device Sequence Number: 8683161
• Product Code: GZF
• UDI-Device Identifier: 00812537037226
• UDI-Public: (01)00812537037226(11)240719(17)270719(10)9457569
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/09/2025

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 Model Number: 72011
• Device Catalogue Number: 72011
• Device Lot Number: 9457569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2024
• 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