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

Model Number	72013
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Temporary leads were placed and bandaged on (b)(6) 2024 and returned to working full duty on the following day.Per the patient, work load includes a 12 hours hift of continuous bending, standing, and pushing.The immediate return to full activities likely caused the leads to move and migrate, both internal and the external portions, leading to loss of stimulation.Infection was confirmed, but type is unknown.Based on patient activity, it is likely that the infection was caused by external sources, however infection is also a known inherent risk of invasive procedures.
Event or Problem Description
On (b)(6) 2024 the patient began the trial phase for a nalu peripheral nerve stimulator system, per the patient, stimulation from the system ceased on (b)(6) 2024 the patient woke up from bed with foul smelling drainage at the incision site.Patient presented to the local emergency department on (b)(6) 2024 and was admitted to the acute facility for iv antibiotics.The firm was not notified of the loss of therapy, drainage, or hospitalization until (b)(6) 2024 when the patient called a nalu representative.Per the patient, the temporary leads "fell out on their own".The date of the leads coming out is unknown.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; calsbad CA 92008
• Manufacturer (Section G): NALU MEDICAL, INC; 2320 faraday ave; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 19717040
• Report Number: 3015425075-2024-00259
• Device Sequence Number: 12794525
• Product Code: GZF
• UDI-Device Identifier: 00812537036175
• UDI-Public: 0100812537036175112110201724102010PZ506
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2024
• Device Model Number: 72013
• Device Catalogue Number: 72013
• Device Lot Number: PZ506
• 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: 06/10/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2021
• 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