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

Model Number 72007

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/10/2023

Event Type  Injury  

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2022 targeting bilateral suprascapular area.Patient reported receiving good pain relief from the system after implant.During a reprograming appointment on (b)(6) 2023 it was noted that the right side lead showed high impedances.Subsequent xray imaging confirmed the right side lead was fractured.Surgical revision was performed on (b)(6) 2023 to replace the fractured lead.

Manufacturer Narrative

Patient is reported to lead a relatively active lifestyle, however there are no reports of any significant event or trauma that may have contributed to the fracture of the implanted lead.The fractured lead was discarded by the medical facility and is thus unavailable for further inspection and investigation by the firm.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Type of Device: 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: 18097774
• MDR Text Key: 327698639
• Report Number: 3015425075-2023-00270
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036342
• UDI-Public: 0100812537036342112208151725081510RK964
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2023

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
• Device Operator: Health Professional
• Device Model Number: 72007
• Device Catalogue Number: 72007
• Device Lot Number: RK964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other