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

Model Number	71007
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient noted, that a current medication is causing repeated falling episodes.Medication is unrelated to the nalu system or the area being treated by the nalu system.Patient reported, an immediate loss of therapy after the nalu system was struck, during a fall.The system was functioning as expected, prior to the patient fall.It is likely, that the system was damaged by the fall.And that the failure is not related to any device deficiency.
Event or Problem Description
Patient was implanted, with the nalu peripheral nerve stimulator system on (b)(6) 2023.To treat shoulder pain.Patient was initially receiving pain relief from the system.In (b)(6) 2023, the patient reported, sustaining a fall on (b)(6) 2023.In which, the implantable pulse generator (ipg) was directly struck.The patient reported, an immediate loss of therapy after the fall.Troubleshooting was attempted and not successful.Xray imaging did not show any migration or damage to the implanted components.On (b)(6) 2024, the patient underwent surgical revision to replace the ipg and the implanted lead.During the revision, there was visual confirmation of damage to the silicone boot, connecting the lead to the ipg.As well as some damage noted, to the lead itself.The physician and the nalu representative present at the procedure noted, that the damage appears to be a result of the patient fall.

• 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: 18919264
• Report Number: 3015425075-2024-00088
• Device Sequence Number: 6410537
• Product Code: GZF
• UDI-Device Identifier: 00812537030999
• UDI-Public: 01008125370309991121091417240914
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K183579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 03/17/2024

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: 09/14/2024
• Device Model Number: 71007
• Device Catalogue Number: 71007
• 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: 02/16/2024
• Initial Report FDA Received Date: 03/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2021
• 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