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

Model Number 71020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

The explanted components were discarded by the medical facility and not available for evaluation and testing by nalu.As a precaution, the patient was also issued new therapy discs at the time of the revision procedure, although the therapy discs are not suspected to be the cause of the communication issues.No further issues have been reported for this patient after relocation of the ipg.

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2022 and subsequently reported issues with communication between the implantable pulse generator (ipg) and the external therapy discs, which was causing disruption of therapy and ultimately inadequate pain relief.The ipg was implanted in the flank of the latissimus dorsi muscle, and it was suspected that the location of the implant was contributing to the connectivity issues.A surgical revision was performed on (b)(6) 2023 to remove the existing ipg and place a new ipg at the top of the trapezius muscle to allow for improved connectivity and ease of accessibility for the patient.

• 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: 17873758
• MDR Text Key: 324960359
• Report Number: 3015425075-2023-00235
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: 01008125370361821122032417250324
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71020
• Device Catalogue Number: 71020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other