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

Model Number	72006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prior to explanting the system, the patient had reported getting 70% pain relief from the nalu system.And there are no indications or allegations of any system or component failure or malfunction.Per the physician, patient had an existing condition with diabetic neuropathy, causing vascular issues in the lower extremity.Patient, was also reported, to have a history of sores on the leg.It appears, that the skin erosion experienced by the patient is likely, related to the patient's pre-existing medical conditions and not caused by the nalu system itself.
Event or Problem Description
Patient was implanted, with a nalu peripheral nerve stimulator system on (b)(6) 2024, to treat lower extremity pain.The implantable pulse generator (ipg) was placed in the patient's calf area, with the attached lead wires targeting the common peroneal nerve.On 06/19/2024, the system was activated and there were no reported issues at that time.On (b)(6) 2024, the patient notified a nalu representative.That the lead wires seem to have eroded through the skin and were exposed.The medical clinic was notified.And the patient was scheduled to be seen the following day.On (b)(6) 2024, a full system explant was performed, due to the exposed implant components.

• 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: 20814984
• Report Number: 3015425075-2024-00447
• Device Sequence Number: 21145716
• Product Code: GZF
• UDI-Device Identifier: 00812537037370
• UDI-Public: 01008125370373701124032617270326109456936
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 12/01/2024

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 Model Number: 72006
• Device Catalogue Number: 72006
• Device Lot Number: 9456936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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