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	Wound Infection (2447)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The nalu representative (rep) reported that the patient was seen for an activation appointment one week post implant.It was noted during the appointment that the ipg incision site is somewhat painful and is oozing clear liquid.The incision is stapled, not red or swollen.The patient reports that they were instructed by someone at the surgery center to remove the post-op dressing on the surgery day.Patient removed the dressing and the surgical sites remained uncovered for the entire week after surgery.It is unknown what staff member gave those instructions of if possibly the patient misunderstood instructions.The physician prescribed an additional round of antibiotics, placed collagen and new bandage over the site.It was further reported that the incision site has fully healed without further intervention.There is no evidence of infection.
Additional Manufacturer Narrative
After conducting a post-acquisition, retrospective review of nalu peripheral nerve stimulation complaint records, boston scientific determined that this event meets mdr reporting criteria.The following mdr information is being submitted as part of capa investigation pcar42.The reported device remains implanted.Follow up shows that the incision site has fully healed without further intervention.

• 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 -724
• Manufacturer (Section G): Nalu Medical, Inc; 2320 faraday ave; suite 100; carlsbad CA 92008 -724
• Manufacturer Contact: rebecca hess ; 2320 faraday ave; suite 100; carlsbad, CA 92008
• MDR Report Key: 50899605
• Report Number: 3015425075-2026-00600
• Device Sequence Number: 17599598
• Product Code: GZB
• UDI-Device Identifier: 00812537036137
• UDI-Public: (01)00812537036137(11)230815(17)260815
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: Lay User/Patient
• Device Expiration Date: 08/15/2026
• Device Model Number: 71005
• 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: 10/17/2023
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2023
• 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