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

Model Number 71019

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

It is likely that the patient's low bmi contributed to instability of the ipg and subsequent communication issues.

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2022 to treat lower back pain.Patient reported difficulty maintaining communication between the implantable pulse generator (ipg) and the external therapy discs immediately after the system was implanted, leading to lack of pain relief.Investigation found that the patient's very low bmi was contributing to the issue as the ipg was unstable in the minimal amount of tissue available beneath the skin.Xray imaging confirmed the ipg and leads were in appropriate locations, had not migrated, and had no obvious damage.On (b)(6) 2024 the nalu system was fully explanted per the patient request.

• 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 CA 92008 7241
• Manufacturer Contact: rebecca hess ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 19056417
• MDR Text Key: 339550192
• Report Number: 3015425075-2024-00122
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036441
• UDI-Public: 01008125370364411122111117251111
• 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: 04/05/2024

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
• Device Operator: Health Professional
• Device Model Number: 71019
• Device Catalogue Number: 71019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other