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

Model Number	71004
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2023.On (b)(6) 2023 the patient notified nalu staff of intermittent communication issues between the implantable pulse generator (ipg) and the external therapy discs, causing intermittent pain therapy.Troubleshooting was attempted, including replacing external devices, however, was unsuccessful.Subsequent fluoroscopy imaging found the ipg position was beyond the recommended depth for optimal connectivity with the therapy discs and also showed that the ipg was hindered by skin folds.Surgical revision on (b)(6) 2023 moved the ipg more superficial, more medial (in firmer tissue), and more superior.
Additional Manufacturer Narrative
Communication issues were not communicated to the firm until approximately 5 months after the patient had the system implanted.It appears that the ipg likely migrated from the original implant location.Migration is a known inherent risk of implantable neuromodulation devices.

• 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
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 17581174
• Report Number: 3015425075-2023-00198
• Device Sequence Number: 8957522
• Product Code: GZF
• UDI-Device Identifier: 00812537033594
• UDI-Public: 01008125370335941121080417240804
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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: 08/04/2024
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Device Lot Number: A01812
• 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: 07/31/2023
• Initial Report FDA Received Date: 08/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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