MAUDE Adverse Event Report: NALU MEDICAL, INC NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR

Model Number	71005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no reports of any system or component failure and patient was receiving therapy from the nalu system until it was explanted.The reported skin erosion occurred approximately 6 months after the initial implant.Cause of erosion is unclear and there are no reports of any external factors that are likely to have contributed to the event.
Event or Problem Description
Patient was implanted with a nalu spinal cord stimulator system on (b)(6) 2024 to treat lower back pain.On (b)(6) 2024 the patient contacted a local nalu representative to report that the implantable pulse generator (ipg) was visibly protruding from the skin where it had been implanted in the lower back area.Patient reported no pain or discomfort at the site and no redness or drainage was noted.Patient was instructed to contact the implanting physician for follow-up and the firm representative also notified the physician of the patient status.On (b)(6) 2024 a full system explant was performed due to the skin erosion with exposed implant.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• 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: 20090744
• Report Number: 3015425075-2024-00319
• Device Sequence Number: 7599664
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: 01008125370361371123081517260815
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/22/2024

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: 08/15/2026
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2023
• 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