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

Model Number 71020

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/10/2023

Event Type  Injury  

Event Description

Patient was implanted with the nalu peripheral nerve stimulator system on (b)(6) 2022.In (b)(6) 2023 the patient was seen in the physician's office and reported attempting to remove what they thought was an ingrown hair, but ended up pulling on one of the implanted nalu leads.Patient underwent surgical debridement and irrigation of the site on (b)(6) 2023 (see mdr 3015425075-2023-00116).After the procedure the patient reported loss of pain therapy from one lead and high impedances from the other lead.Reprogramming was somewhat effective in restoring therapy but not fully effective.Patient and physician decided to fully remove the nonfunctioning system and allow the site to fully heal before planning a re-implant of a new system.

Manufacturer Narrative

There was no allegation of system or component failure prior to the patient pulling on one of the implanted leads in (b)(6) 2023.Lead moved from the original intended position when pulled and no longer provided therapy.Suspect the system was further damaged during debridement and irrigation procedures as there was no report of impedance issues prior to that procedure.

• 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: 17660968
• MDR Text Key: 322381954
• Report Number: 3015425075-2023-00225
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00812537036182
• UDI-Public: 01008125370361821122030117250301
• 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: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• 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
• Device Lot Number: A03410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other